Responsibilities

The Clinical Research Associate will perform the following duties:

Project related duties include:

1. Handle Clinical Study projects in a team with complete accountability
2. Preparation of Clinical Trial documents (like Study Protocols, Informed Consent Documents, Case Report Forms, Investigator’s Brochure etc.) on available templates.
3. Prepare Clinical Trial Agreements and negotiate budgets with sites
4. Conduct Study feasibilities
5. Support in Pre-study and Post study duties
6. Support in preparing for Ethics Committee and Regulatory Submissions
7. Support in in-house coordination of the studies and support senior members of the team
8. Prepare Presentations for Investigator Meeting and Regulatory Agencies
9. Support senior colleagues in Conduct Site Selection, Study Initiation, Routine Monitoring and Close-out Visits
10. Support senior colleagues in coordinating Safety Reporting
11. Support in building Clinical Trial Databases
12. Support in Data verification, collection of complete data, support cleaning, analysis of data and compilation of report
13. Support in Investigational Product Management and control
14. Maintain essential documents in-house and the oversee the maintenance at the site
15. Perform travel as Required for Site Monitoring and Other Activities
16. Perform any other tasks assigned by management from time to time

Non-Project related duties:

1. Mentor CRCs
2. Prepare Clinical SOPs
3. Prepare training materials
4. Help in regulatory filing
5. Interface with clients, sites and investigators when required
6. Participate in business meetings make presentation when required
7. Accomplish jobs assigned from time to time to meet satisfaction of the management
8. Work in alignment with the company objectives and common goal of the company
9.