lavori da Laboratory in località United States

MAJOR DUTIES AND RESPONSIBILITIES

(A) SPECIFIC (90%)

1. Liaison person with Principal Investigator (PI) and site-PI.
2. Liaison person with various departments for clinical research procedures e.g. Specialist Clinics, Laboratory, wards, etc.
3. Adherence to protocol procedure.
4. Screening and recruiting suitable candidates as research participants.
5. Explain protocol to research participants and ensure that informed consent is taken as per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) and Human Biomedical Research Act (HBRA) requirements
6. Contact and schedule appointments for research subjects within the time frame required in the protocol.
7. Centrifuge blood specimens and send specimens to laboratory.
8. Tracing and returning of case notes, blood results and all other results required in the protocol.
9. Responsible for data collection and performing research procedures.
10. Maintain documentation of patient reimbursement logs, hardcopy and electronic case report forms.
11. Maintain source documentation for each patient accordance to protocol requirements.
12. Identify, document and submit protocol deviations to Institutional Review Board (IRB) according to hospital and sponsor procedures.
13. Inform PIs and collaborators on any adjustments based on protocol change.
14. Complete, report and follow up on unanticipated problems involving risk to subjects and adverse events and/or serious adverse events
15. Work with in-house Research Database IT Specialist on extraction of patient medical records and data mining.
16. Traveling to research participants’ house may be required.

(B) GENERAL (10%)

1. To participate in projects and activities as assigned by Director, Clinical Research Unit

JOB REQUIREMENTS

(A) EDUCATION, TRAINING AND EXPERIENCE

• Minimum Diploma in Biomedical Science or equivalent
• Experience as a Research Assistant will be preferred