- The Clinical Research Coordinator (CRC), as delegated by the principal investigator, executes and coordinates dailyclinical research activities according to Protocol, GCP and Regulatory guidelines. Working under the direction of the principal investigator, the CRC's responsibilities include:
1. Becoming thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable) and study medication(s) for the assigned research study;
2. Ensuring IRB approved protocols are implemented and followed;
3. Executing informed consent process and monitoring patient status and safety;
4. Managing and participating in study recruitment to ensure enrollment goals are met or exceeded;
5. Maintaining and dispensing study product and supplies;
6. Collecting and organizing research data;
7. Scheduling and conducting study specific training and site in-services to study-related staff on new or amended protocols;
8. Completing and ensuring the quality of case report forms;
9. Maintaining source documents;
10. Ensuring site quality.
11. Other job related duties as required
Keyskills
Desired Candidate Profile
Education-
- Graduates in Lifesciences / B. Pharm / M.Pharm OR an equivalent combination of education and experience is required (Freshers may also apply).
Must have good knowledge of Good Clinical Practice and Regulatory (Schedule Y) Guidelines
Must be proficient with Microsoft office applications (Outlook, Word and Excel) as well as internet based applications;
Must be detail oriented, organized, self-motivated, be able to work independently and on a team, and the ability to stay on task;
Must have excellent written and verbal communication, teamwork and problem solving skills;
Must be professional, possess a high degree of self-motivation and have a strong work ethic.
Must have the ability to adapt and take-on additional tasks as requested;
Must be capable of recognizing, and have the willingness, to resolve errors and issues;
Must possess a high degree of integrity and the ability to maintain the utmost confidentiality in all company matters.
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