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
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