JOB SPECIFICATION/REQUIREMENTS

• Life science diploma/ degree or nursing degree is preferred. The relevant degree subject area is life science or biomedical science.
• Ability to work both independently and in a team.
• Good communication skills.
• Good patient interaction skills.
• Be flexible and self-motivated.
• Ability to write clearly
• Possess excellent organisational skills.
• Enjoy paying attention to detail.
• Computer literacy.
• Ability to work flexibly with occasional weekends and late nights.

JOB PURPOSE

• A clinical research coordinator will assist Principal Investigator or Co-investigators to monitor the administration and progress of a clinical trial.

DUTIES AND RESPONSIBILITIES

Primary Duties and Responsibilities

Clinical Trial

• 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.

Secondary Duties and Responsibilities

Recruitment Plan

• To work with company in developing and implementing recruitment plan to ensure long-term recruitment target is met.