Assumes responsibility for effective management of research protocols initiated at Great Lakes Research Institute including but not limited to:
Patient recruitment and consent, Scheduling and retention in addition to scheduled visits for study events
Creates protocol specific documentation reference tools and source documents
Management of patient visits, documentation and binders for the study.
Responsible for day-to-day regulatory management including, DOA, SAE reporting, deviations, and amendment review.
Assures adherence to safety guidelines and protocol schedule for patient treatment with oversight of the Principal and Sub-Investigators.
Organization and coordination of Monitor/audit visits as required
Responsible for EDC data entry and addressing of any queries generated
Additional responsibilities will be assigned as needed
· Three years of relevant experience in clinical research
· Blood draw experience
· Experience with EDC and Source Data (eSource a plus)
· Basic understanding of regulatory
· Experience with Microsoft Office
Knowledge of good clinical practice, FDA, OHRP, HIPAA policies
Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.
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