Senior Clinical Research Associate

Duties and Responsibilities:
1. Responsible for the management of designated clinical trials including investigator selection, analysis of potential patient recruitment, preparation of trial related documentation (protocols, Case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organising Ethics committee submissions with follow through to ensure successful outcome.
2. Organise investigator’s start-up meeting and study site initiation meetings.
3. Plan, implement and coordinate all aspects of data collection, recording and source documentation, as per hospital and unit policy and ICH/GCP guidelines.
4. Monitoring the assigned clinical trial following company SOPs and in accordance with GCP.
5. Review all SAEs, ensure Medical Manager sign-off, that sites are notified and that all company procedures are complied with.
6. Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.
7. Liaise with colleagues in monitoring, data management and laboratory departments to ensure quality and harmonious execution of study procedures.
8. Review the translated medical documents, the package inserts and report writing. Coordinates report and protocol-writing activities.
9. Other tasks as required.

1. Health related universities. (Medical doctor /Public health/ Pharmacist).
2. In-depth knowledge of Good Clinical Practice (GCP) and local regulations and processes
3. Monitoring/CRA experience
4. Experience with coordinating other CRAs or leading a team
5. Excellent organization and management skills
6. Fluency in writing and reading English
7. Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System, Electronic Documents Management System, MS-Office products such as Excel and Word
8. Good communication skills
9. Administrative excellence
10. Self-motivated and proactive

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