Clinical Research Associate Job Description "A"

Clinical Research Associate

Job Description

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. Coordinate the movement of laboratory samples and the resulting data when central laboratory facilities are used.
4. Ensure procedures are in place for appropriate optimisation of patients into the clinical trial.
5. Monitoring the assigned clinical trial following company SOPs and in accordance with GCP.
6. Planning the requirements for clinical trial material, ordering clinical trial material (head office or local comparators), setting up and monitoring the systems whereby the Clinical Research Assistant can ship CT material to the investigator, maintaining procedures to account for the CT material, checking the expiration of CT material and requesting extensions if necessary.
7. Be the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials.
8. Participate in global conference calls and meetings to review progress of ongoing clinical trials.
9. Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.
10. Manage patient recruitment strategies to increase patient randomisation into the trial (eg  investigator and research nurse meetings, update newsletters, advertising, letters to GPs).
11. Review all SAEs, ensure Medical Director sign-off, that sites are notified and that all company procedures are complied with.
12. 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.
13. Manage the Contract Research Organisations – initial identification of a suitable partner, definition of CRO responsibilities, communication plan, divisions of responsibility, milestones, contract with CRO, review monthly status reports, and the interactive management of CRO to ensure project success.
14. Participate in departmental planning sessions, and SOP development.
15. Provide management to the clinical research assistants to ensure that their role and contribution is optimised.