
Clinical Research Coordinator
2 days ago
Job Description:
A clinical research coordinator will assist Principal Investigator or Co-investigators to monitor the administration and progress of a clinical trial.
The Challenges
- Oversee overall clinical operations related to the conduct of the clinical trials.
- To adhere to compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements.
- To ensure the study and study procedures are conducted in accordance with the study protocol
- To participate in patient recruitment.
- To ensure study entry criteria are fulfilled.
- To ensure informed consent procedure is followed.
- To coordinate patient visits for future tests and procedures.
- To schedule visit according to study protocol.
- To organize and participate in site initiation visit.
- To work in collaboration with study team to ensure trial preparedness.
- To monitor patients throughout the study to ensure study drugs are given according to protocol requirement.
- To arrange for clinical and laboratory investigations to be carried out according to protocol.
- Ensure results of investigations and X-ray films are collected.
- Maintains records of additional investigations for invoicing purposes.
- To collects and collates research data, ensuring its accuracy and completeness.
- Ensure timely and accurate transcription of information on source documents, paper case report forms (CRFs), or electronic CRFs.
- To label and ensure biological specimens are delivered in the correct conditions as specified in the trial protocol.
- To assist investigator(s) in adverse events / serious adverse events reporting.
- To maintain confidentiality on patient data.
- To work with pharmacy to maintain drug accountability logs.
- To raise payment request forms for billing to companies
- Creation and maintenance of all trial files, including the trial master file, and oversight of site files.
- To work with company in developing and implementing recruitment plan to ensure long-term recruitment target is met.
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