Prepare for or participate in quality assurance audits conducted by study sponsors, or specially designated review groups.Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents and progress reports.Coordinate with PIs and department to help ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement.Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.Coordinate and facilitate monitoring and auditing visits. Notify appropriate institutional officials of external audits.Work collaboratively with the other members of the clinical research team and the clinical and administrative support team to ensure protocols are followed and that there is timely documentation and submission of study data.

Oversee subject enrollment to ensure that informed consent is properly obtained and documented.Coordinate with sponsors to schedule and coordinate site visits, routine monitoring visits, and study close out visits.Attend Investigator meetings and report pertinent information back to research team members.Review and comprehend each assigned protocol including study proceedings and timelines.Complete documentation on each study visit that is used to track all study related activities so that time, effort and material can be accounted for on a monthly basis.Ensures that all material for each clinical trial protocol are available for subject enrolment.Establish and organize study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.Arrange secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time.

Serve as a patient liaison to the Principal Investigator (PI) and other participating physicians.Patient recruitment & patient handling.Scheduling study subject appointments.Filling CRF & taking informed consent.Maintains records and other documentation of training.Maintains subject screening logs and protocol deviation logs.Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.Respond to data clarification requests in a timely manner.Direct the requisition, collection, labeling, storage, or shipment of specimen.