Clinical Research Coordinator
1 week ago
JOB ANNOUNCEMENT - CLINICAL RESEARCH COORDINATOR
Position:
Clinical Research Coordinator
Full-time, based in Hanoi
Report to:
Clinical Research Manager & Investigator of Record (IoR)
Position Summary:
The Clinical Research Coordinator (CRC) will oversee and perform daily clinical trial activities to ensure the studies are conducted in compliance with protocols, local and international requirements.
By performing these duties, the CRC works with participants, Clinicians, and other study staff, IoR, PIs, Lab team, Pharmacy team, Recruitment team, UNC-CH experts, monitors, and IRBs to provide guidance and support on routine tasks at clinical research sites, technical issues and other related aspects of all ongoing clinical studies.
Duties & Responsibilities:
- Develop SOPs on clinical and safety activities for clinical trials based on throughout understanding of the protocols.
- Develop study tools and forms to record study data per protocols, GCP, networks, sponsors, IRBs and other regulatory entities requirements.
- Provide training and technical assistance for clinicians and other study staff on daily study activities.
- Provide training and technical assistant for clinicians on informed consent process. Ensures that the informed consent process is conducted per applicable regulations.
- Assess the inclusion and exclusion criteria for participant enrollment and verify participant's documents for randomization.
- Perform monitoring activities on daily basis, ensuring compliance of clinical activities with protocol, GCP, Vietnam laws and regulations, including but not limited to reviewing informed consent, participant chart, AE/SAE report, etc.
- Ensure that AEs and participant safety are managed per applicable requirements. Complete AE/SAE and safety reports to send to IoR, PI, sponsor, and IRB in a timely manner.
- Ensure that the study documents are kept and maintained per current regulations.
- Work closely with the clinical management committee (CMC) to seek advice on dealing with difficult cases and situations.
- Ensure that the study documents are kept and maintained per current regulations.
- Promote study participant recruitment and retention in the research studies.
- Translate study documents from English into Vietnamese and vice versa.
- Be a role model, share best practices and make recommendations for continuous quality improvement in clinical activities.
- Attend studyspecific and studyrelated training and meetings as requested.
- May perform other jobrelated duties as requested or required.
Required qualifications and skills:
- Possess a MD degree.
- Fluent in both spoken and written English.
- Excellent adaptability, interpersonal and organizational skills.
- Attention to detail.
Salaries and Benefits:
Competitive salary
How to Apply:
- Job Details
Organisation Name:
- UNC
Location: - Hanoi
Application Deadline: - Sun,
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