- Interviewing and enrolling eligible participants into the study.
- Responsible for ensuring that any study under his/her supervision is in compliance with good clinical practice guidelines.
- Ensure that forms detailing a study are correctly filled out and are properly filed.
- Compilation, collection and documentation of research data.
- Responsible for enrolling patients and assuring compliance for all patients.
- Play an integral role in managing the overall site staff, this involves human resource and logistical issues.
- Oversee overall clinical operations related to conduct of the trial (i.e. recruitment, informed consent procedure, visit coordination, sampling, visit scheduling, etc).
- Work in collaboration with study team to ensure trial preparedness.
- Attend and participate in investigators meetings, stakeholders meetings, and other meetings as needed.
Serve as point person at the clinical site for monitoring needs.
- Prepare monitoring visits to make sure monitors receive all necessary information during their visits.
- Review protocol with the clinical team and ensure clinical team is aware of their roles and responsibilities.
- Develop reporting mechanism for bringing critical and high priority issues to the investigators, study sponsors, and/or the monitors.
- Develop an internal system for quality assurance.
- Play a role in developing and implementing a patient recruitment plan to ensure long-term recruitment target is met.
- Develop or improve system of maintaining subject files.
- Ensure timely and accurate transcription of information on source documents, paper case report forms (CRFs), and electronic CRFs.
- Schedule trainings as needed for the site staff.
- Participate in data query resolution process.
Education:Post Graduate with Diploma in Clinical Research/ M.Sc Clinical Research
Education:UG -B.Sc – Any Specialization
PG – M.Sc, PG Diploma