37 Clinical Internship jobs in Hong Kong

Clinical Research Associate

Tigermed

Posted 10 days ago

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Job Description

Direct message the job poster from Tigermed

1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.

1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2.Responsibilities

(a) Site management

•Study site selection, initiation (SIV) and clinical monitoring.

•Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.

•Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.

•Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.

•Track study recruitment to ensure recruitment target is achieved in all studies.

•Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.

•Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.

•Assemble site specific EC submission dossier, and ensure submission to EC.

Training

•Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.

•Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

Documentation

•Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.

•Prepare/complete study records’ archiving according to protocol and sponsor requirements.

(b) Drug Safety

•Ensure safety information is disseminated to all sites according SOP and applicable regulations.

•Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

(c) Finance and Administration

•Finalize budget and obtain signed contract from site, prior to site initiation visit.

•Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(d) Study Tools and system

•Update and maintain Study tools/systems in a timely manner.

3. Qualifications

3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements;

3.2 At least 1 year of CRA experience;

3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;

3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Seniority level
  • Seniority level Associate
Employment type
  • Employment type Full-time
Job function
  • Job function Research
  • Industries Pharmaceutical Manufacturing

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Research Assistant (Fresh Graduates Welcome)

Islands District, Hong Kong SAR 11 hours ago

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Clinical Research Associate

Hong Kong, Hong Kong Tigermed

Posted today

Job Viewed

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Job Description

Direct message the job poster from Tigermed

1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.

1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2.Responsibilities

(a) Site management

•Study site selection, initiation (SIV) and clinical monitoring.

•Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.

•Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.

•Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.

•Track study recruitment to ensure recruitment target is achieved in all studies.

•Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.

•Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.

•Assemble site specific EC submission dossier, and ensure submission to EC.

Training

•Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.

•Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

Documentation

•Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.

•Prepare/complete study records’ archiving according to protocol and sponsor requirements.

(b) Drug Safety

•Ensure safety information is disseminated to all sites according SOP and applicable regulations.

•Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

(c) Finance and Administration

•Finalize budget and obtain signed contract from site, prior to site initiation visit.

•Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(d) Study Tools and system

•Update and maintain Study tools/systems in a timely manner.

3. Qualifications

3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements;

3.2 At least 1 year of CRA experience;

3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;

3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Seniority level
  • Seniority level Associate
Employment type
  • Employment type Full-time
Job function
  • Job function Research
  • Industries Pharmaceutical Manufacturing

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Research Assistant (Fresh Graduates Welcome)

Islands District, Hong Kong SAR 11 hours ago

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Clinical Research Associate (MJ000011)

Tigermed

Posted 10 days ago

Job Viewed

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Job Description

3 days ago Be among the first 25 applicants

Direct message the job poster from Tigermed

1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.

1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2.Responsibilities

(a) Site management

•Study site selection, initiation (SIV) and clinical monitoring.

•Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.

•Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.

•Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.

•Track study recruitment to ensure recruitment target is achieved in all studies.

•Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.

•Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.

•Assemble site specific EC submission dossier, and ensure submission to EC.

Training

•Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.

•Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

Documentation

•Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.

•Prepare/complete study records’ archiving according to protocol and sponsor requirements.

(b) Drug Safety

•Ensure safety information is disseminated to all sites according SOP and applicable regulations.

•Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

(c) Finance and Administration

•Finalize budget and obtain signed contract from site, prior to site initiation visit.

•Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(d) Study Tools and system

•Update and maintain Study tools/systems in a timely manner.

3. Qualifications

3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements;

3.2 At least 1 year of CRA experience;

3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;

3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Seniority level
  • Seniority level Associate
Employment type
  • Employment type Full-time
Job function
  • Job function Research
  • Industries Pharmaceutical Manufacturing

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Sign in to set job alerts for “Clinical Research Associate” roles. Temporary / Part-time Research Assistant I (N&HS) Temporary / Part-time Research Assistant I (N&HS) - (25001MB)

Islands District, Hong Kong SAR 2 weeks ago

Research Assistant II (R7045) (N&HS) - (25001L1) Research Assistant (Fresh Graduates Welcome) Clinical Research Associate II, Hong Kong Clinical Trials Assistant (CTA) (Evergreen)

Kwai Tsing District, Hong Kong SAR 2 weeks ago

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Clinical Research Associate (MJ000011)

Hong Kong, Hong Kong Tigermed

Posted 3 days ago

Job Viewed

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Job Description

3 days ago Be among the first 25 applicants

Direct message the job poster from Tigermed

1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.

1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2.Responsibilities

(a) Site management

•Study site selection, initiation (SIV) and clinical monitoring.

•Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.

•Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.

•Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.

•Track study recruitment to ensure recruitment target is achieved in all studies.

•Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.

•Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.

•Assemble site specific EC submission dossier, and ensure submission to EC.

Training

•Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.

•Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

Documentation

•Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.

•Prepare/complete study records’ archiving according to protocol and sponsor requirements.

(b) Drug Safety

•Ensure safety information is disseminated to all sites according SOP and applicable regulations.

•Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

(c) Finance and Administration

•Finalize budget and obtain signed contract from site, prior to site initiation visit.

•Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(d) Study Tools and system

•Update and maintain Study tools/systems in a timely manner.

3. Qualifications

3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements;

3.2 At least 1 year of CRA experience;

3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;

3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Seniority level
  • Seniority level Associate
Employment type
  • Employment type Full-time
Job function
  • Job function Research
  • Industries Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Tigermed by 2x

Sign in to set job alerts for “Clinical Research Associate” roles. Temporary / Part-time Research Assistant I (N&HS) Temporary / Part-time Research Assistant I (N&HS) - (25001MB)

Islands District, Hong Kong SAR 2 weeks ago

Research Assistant II (R7045) (N&HS) - (25001L1) Research Assistant (Fresh Graduates Welcome) Clinical Research Associate II, Hong Kong Clinical Trials Assistant (CTA) (Evergreen)

Kwai Tsing District, Hong Kong SAR 2 weeks ago

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Clinical Development Engineer (Medical Device)

Cornerstone Robotics

Posted 10 days ago

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Job Description

Clinical Development Engineer (Medical Device)

1 day ago Be among the first 25 applicants

Direct message the job poster from Cornerstone Robotics

The Clinical Development Engineer is responsible for contributing to the clinical development of a surgical robotic system. The successful candidate must excel in a high-energy environment, possess excellent interpersonal skills, and have experience in the medical device or robotics field.

Responsibilities

  • Perform the creation of clinical procedure materials such as procedure guides, set-up cards, and clinical videos to enable training for both internal and external customers.
  • Offer clinical support for medical robots, addressing technical issues, user questions, or other problems to ensure optimal functioning and satisfaction of physicians and patients.
  • Analyze workflows and needs of physicians to determine specific clinical requirements for medical robot systems.
  • Collaborate across the Company, especially on regulatory, human factors, usability, and quality to ensure alignment with regulatory objectives.
  • Assist in the creation of clinical design validation protocols and reports.
  • Perform other ad-hoc tasks/projects as assigned.

Qualification

  • Bachelor's degree or above in Biomedical Engineering or a relevant field. Fresh graduates will also be considered.
  • Affinity with clinical environments and medical devices.
  • A good understanding, and preferably proven experience, of the medical product development process related to surgical devices in a regulated environment.
  • Strong problem-solving and interpersonal skills.
  • Fluency in written and spoken English is mandatory.
Seniority Level

Associate

Employment Type

Full-time

Job Function

Other

Industries

Medical Equipment Manufacturing

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Clinical Assistant Professor of Practice

HKUMed – The University of Hong Kong

Posted 10 days ago

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Job Description

Clinical Assistant Professor of Practice

Join to apply for the Clinical Assistant Professor of Practice role at HKUMed – The University of Hong Kong

Clinical Assistant Professor of Practice

1 day ago Be among the first 25 applicants

Join to apply for the Clinical Assistant Professor of Practice role at HKUMed – The University of Hong Kong

Applications are invited for appointment as Clinical Assistant Professor of Practice in the Department of Family Medicine and Primary Care, School of Clinical Medicine (Ref.: 531830), to commence as soon as possible, on a three- to four-year fixed-term basis, with the possibility of renewal subject to funding availability and satisfactory performance.

The Department of Family Medicine and Primary Care, School of Clinical Medicine aims to educate doctors to practise medicine at the highest standard, prioritising the best interests of their patients and the community, and to inspire them to strive for and achieve academic excellence. The mission of the Department is to promote quality primary care through education, patient-centred service and research in family medicine.

Applicants should possess a primary medical qualification registrable with the Medical Council of Hong Kong and a higher qualification in general practice/family medicine, preferably holding a FHKAM (Family Medicine) or equivalent specialist qualification. They should demonstrate excellence in clinical services; have a strong commitment and experience in undergraduate teaching; and exhibit the capacity and potential in research. They should also be fluent in English as teaching, research and professional activities are conducted in English.

The appointee is expected to participate in the planning and delivery of undergraduate and postgraduate medical education programmes in Family Medicine; conduct clinical research; develop and provide clinical services in primary care in the HKUMed affiliated hospitals and clinics; and contribute to administrative duties in the Department, Faculty and University. Information about the post can be obtained from Professor William Wong at .

A highly competitive salary commensurate with qualifications and experience will be offered, in addition to annual leave and medical benefits. At current rates, salaries tax does not exceed 15% of gross income. The appointment will attract a contract-end gratuity and University contribution to a retirement benefits scheme, totaling up to 15% of basic salary. A monthly cash allowance will be offered to the successful candidate. Housing benefits will also be provided as applicable.

The University only accepts online application for the above post. Applicants should apply online and upload an up-to-date curriculum vitae including a publication list highlighting their best papers. Review of applications will start from June 27, 2025 and continue until August 27, 2025 , or until the post is filled, whichever is earlier.

Seniority level
  • Seniority level Mid-Senior level
Employment type
  • Employment type Full-time
Job function
  • Job function Health Care Provider
  • Industries Higher Education

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Get notified about new Clinical Assistant jobs in Hong Kong SAR .

Hong Kong SAR HK$16,000.00-HK$7,999.00 3 days ago

Kowloon City District, Hong Kong SAR 1 week ago

Temporary Research Assistant (Project No.: R6628) (E&L) Clinical Trials Assistant (CTA) (Evergreen)

Kwai Tsing District, Hong Kong SAR 1 week ago

Research Assistant (Fresh Graduates Welcome) Temporary Research Assistant (Project No.: R6628) (E&L) - (25001E5)

Hong Kong SAR HK 16,135.00-HK 16,135.00 16 hours ago

Kowloon City District, Hong Kong SAR 1 month ago

Research Assistant I/II (Ref.: H01/2025/067) Temporary Research Assistant I (Project Code: RD/2023/2.6) (A&SS) Clinical Research Associate II (Hong Kong)

Hong Kong SAR HK 17,610.00-HK 18,550.00 3 weeks ago

Temporary Research Assistant II (N&HS) - (25001CC)

Hong Kong SAR HK 12,000.00-HK 13,999.00 5 days ago

Company Secretarial Assistant - Fresh Graduates Welcome (Up to 20K/mth) Assistant Manager, Corporate Medical and Wellness Account

Wan Chai District, Hong Kong SAR 11 months ago

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Clinical Trials Assistant (CTA) (Evergreen)

Hong Kong, Hong Kong IQVIA

Posted 10 days ago

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Job Description

Clinical Trials Assistant (CTA) (Evergreen)

Join to apply for the Clinical Trials Assistant (CTA) (Evergreen) role at IQVIA

Clinical Trials Assistant (CTA) (Evergreen)

1 day ago Be among the first 25 applicants

Join to apply for the Clinical Trials Assistant (CTA) (Evergreen) role at IQVIA

Job Overview

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Job Overview

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

  • Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
  • Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
  • Assist with periodic review of study files for completeness.
  • Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
  • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
  • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
  • May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Qualifications

  • High School Diploma or equivalent Req.
  • 3 years administrative support experience.
  • Equivalent combination of education, training and experience.
  • Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
  • Written and verbal communication skills including good command of English language.
  • Effective time management and organizational skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
  • Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
  • Knowledge of applicable protocol requirements as provided in company training.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

Seniority level
  • Seniority level Entry level
Employment type
  • Employment type Full-time
Job function
  • Job function Research, Analyst, and Information Technology
  • Industries Pharmaceutical Manufacturing

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Get notified about new Clinical Trial Assistant jobs in Kwai Tsing District, Hong Kong SAR .

Temporary Research Assistant I / Research Assistant II Part-time Research Assistant II (R6681) (S&T) Temporary Research Associate/Research Assistant I/Research Assistant II

Hong Kong SAR HK$13,110.00-HK$13,110.00 12 hours ago

Temporary Research Assistant I / Research Assistant II - (25001HL) Research Assistant (Fresh Graduates Welcome) Temporary Research Associate/Research Assistant I/Research Assistant II - (25001HN)

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Tenure-track Clinical Associate Professor

HKUMed – The University of Hong Kong

Posted 10 days ago

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Tenure-track Clinical Associate Professor

Join to apply for the Tenure-track Clinical Associate Professor role at HKUMed – The University of Hong Kong

Tenure-track Clinical Associate Professor

5 days ago Be among the first 25 applicants

Join to apply for the Tenure-track Clinical Associate Professor role at HKUMed – The University of Hong Kong

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Applications are invited for appointment as Tenure-track Clinical Associate Professor in the Department of Family Medicine and Primary Care, School of Clinical Medicine (Ref.: 531771), to commence as soon as possible, on a four-year fixed-term basis, with the possibility of renewal and consideration for tenure before the expiry of a second four-year fixed-term contract, subject to satisfactory performance.

The Department of Family Medicine and Primary Care, School of Clinical Medicine aims to educate doctors to practise medicine at the highest standard, prioritising the best interests of their patients and the community, and to inspire them to strive for and achieve academic excellence. The mission of the Department is to promote quality primary care through education, patient-centred service and research in family medicine.

Applicants should possess a primary medical qualification registrable with the Medical Council of Hong Kong and a higher qualification in general practice/family medicine, preferably holding a FHKAM (Family Medicine) or equivalent specialist qualification. They should demonstrate excellence in clinical services; have a strong commitment and experience in undergraduate teaching; and exhibit the capacity and potential in research. They should also be fluent in English as teaching, research and professional activities are conducted in English. The appointee should possess experience in academic family medicine, with a proven track record of research leadership and publications.

The appointee is expected to participate in the planning and delivery of undergraduate and postgraduate medical education programmes in Family Medicine; conduct clinical research; develop and provide clinical services in primary care in the HKUMed affiliated hospitals and clinics; and contribute to administrative duties in the Department, Faculty and University. Information about the post can be obtained from Professor William Wong at .

A highly competitive salary commensurate with qualifications and experience will be offered, in addition to annual leave and medical benefits. At current rates, salaries tax does not exceed 15% of gross income. The appointment will attract a contract-end gratuity and University contribution to a retirement benefits scheme, totaling up to 15% of basic salary. A monthly cash allowance will be offered to the successful candidate. Housing benefits will also be provided as applicable.

The University only accepts online application for the above post. Applicants should apply online and upload an up-to-date curriculum vitae including a publication list highlighting their best papers. Review of applications will start from June 27, 2025 and continue until August 27,2025, or until the post is filled, whichever is earlier.

Seniority level
  • Seniority level Mid-Senior level
Employment type
  • Employment type Full-time
Job function
  • Job function Education and Training
  • Industries Higher Education

Referrals increase your chances of interviewing at HKUMed – The University of Hong Kong by 2x

Sign in to set job alerts for “Clinical Associate Professor” roles. Clinical Associate Professor of Practice Clinical Associate Professor of Practice/ Clinical Assistant Professor of Practice (several posts) Tenure-Track Clinical Associate Professor/ Clinical Assistant Professor Tenure-Track Clinical Associate Professor/Clinical Assistant Professor (several posts) Tenure-Track Clinical Associate Professor/Clinical Assistant Professor in Periodontology of the Faculty of Dentistry Clinical Professor of Practice (several posts) Tenure-Track Clinical Professor (several posts) Tenure-Track Clinical Professor/Clinical Associate Professor in Oral and Maxillofacial Radiology Tenure-Track Professor/Associate Professor/Assistant Professor in Emergency Medicine Therapeutics & Diagnostics

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Clinical Research Associate (Hong Kong)

Fortrea

Posted 10 days ago

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Job Description

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Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer

Summary Of Responsibilities

  • Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
  • Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
  • Prepares and implements project plans related to Clinical Monitoring responsibilities.
  • Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
  • Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
  • Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
  • Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
  • Ensures adherence to global quality control and CRA performance metrics.
  • Ensures audit readiness at site level.
  • Acts in the project role of a Lead CRA as assigned.
  • General On-Site Monitoring Responsibilities:
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.
  • Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
  • Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
  • Travel, including air travel, may be required and is an essential function of the job.
  • Prepare and submit accurate and timely trip reports.
  • Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.
  • Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.
  • Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.
  • Track IP shipments and supplies, as needed.
  • Track and follow-up on serious adverse events as assigned.
  • Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.
  • Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
  • Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed.
  • Present training content for site initiation.
  • Assist with training of new employees (e.g., co-monitoring).
  • All other duties as needed or assigned.

Qualifications (Minimum Required)

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
  • Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
  • Thorough knowledge of monitoring procedures.
  • Basic understanding of the clinical trial process.
  • Fluent in local office language and in English, both written and verbal.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required)

  • External Candidates:
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND
  • A minimum of 2 years of Clinical Monitoring experience.
  • Internal Candidates:
  • Internal candidates with a minimum of 2 years of Clinical Monitoring experience.
  • Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
  • Ability to work with minimal supervision.
  • Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
  • Good planning, organization, and problem-solving abilities.
  • Works efficiently and effectively in a matrix environment.

Preferred Qualifications Include

  • Thorough working knowledge of Fortrea SOPs for site monitoring.
  • One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
  • Phase I monitoring experience.
  • Life Science or Nursing qualification.
  • Specific skills, systems, certifications, and/or licenses preferred.
  • Personal characteristics (leadership, problem solving, interpersonal skills).
  • Good attention to detail.
  • Methodical approach to work.
  • Good understanding of medical and clinical research terminology and clinical research processes.
  • An understanding of the basics of physiology, pharmacology, and medical devices (when applicable).
  • Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements.
  • Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
  • Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.
  • Focus on Customer.
  • Innovate and Change.
  • Pursue Scientific and Process Excellence.
  • Work with Others.
  • Achieve Results.
  • Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
  • Demonstrated ability to conduct clinical operations activities most effectively and efficiently.
  • Good analytical and negotiation skills.
  • Experience using e-clinical systems (e.g., clinical trial management system (CTMS)).
  • For medical device positions, experience in providing customer service to device end users.

Physical Demands/Work Environment

  • Must be able to sit at a computer for long periods of time.
  • Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day.
  • Standard office and/or home working environment.
  • Clinical Research Unit and hospital environment (administrative only).
  • Risk of eye strain.
  • Will involve outside of normal office hours as required by the role.
  • Travel Requirement is 60% of the time (traveling to study sites).

Learn more about our EEO & Accommodations request here.

Seniority level
  • Seniority level Entry level
Employment type
  • Employment type Full-time
Job function
  • Job function Research, Analyst, and Information Technology

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Tenure-Track Clinical Assistant Professor

HKUMed – The University of Hong Kong

Posted 10 days ago

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Tenure-Track Clinical Assistant Professor

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Applications are invited for appointment as Tenure-Track Clinical Assistant Professor in the Department of Microbiology, School of Clinical Medicine (Ref.: 531392), to commence as soon as possible, on a four-year fixed-term basis, with the possibility of renewal and consideration for tenure before the expiry of a second four-year fixed-term contract, subject to satisfactory performance.

Applicants should possess a medical qualification registrable with the Hong Kong Medical Council, and postgraduate professional qualifications in clinical disciplines in relation to clinical microbiology and infectious diseases. They should demonstrate a strong commitment to and evidence of excellence in teaching and its development, preferably in clinical microbiology and infectious diseases, to help advance the strengths of the Department’s teaching in the broad spectrum of medical and health sciences education. They should be able to conduct courses at both undergraduate and postgraduate levels; supervise postgraduate research students; demonstrate the potential for conducting independent research by track record on research publications; and also demonstrate broad knowledge and clinical experience in clinical microbiology and infectious diseases, preferably from laboratory to the bedside.

The appointee will participate in, organize and develop undergraduate and postgraduate teaching programmes; conduct research; provide clinical services at the University’s teaching hospitals; and contribute to administrative duties in the Department and Faculty. Information about the Department can be obtained at .

Applicants who have responded to the previous advertisement (Ref.: 527348) need not re-apply.

A highly competitive salary commensurate with qualifications and experience will be offered, in addition to annual leave and medical benefits. At current rates, salaries tax does not exceed 15% of gross income. The appointment will attract a contract-end gratuity and University contribution to a retirement benefits scheme, totalling up to 15% of basic salary. A monthly cash allowance will be offered to the successful candidate. Housing benefits will also be provided as applicable.

The University only accepts online application for the above post. Applicants should apply online and upload an up-to-date C.V. and at least 3 reference letters. Review of applications will start as soon as possible and continue until September 19, 2025, or until the post is filled, whichever is earlier.

Seniority level
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