SLOCUM ORTHOPEDICS, P.C.
Clinical Research Coordinator (Project Management)
Essential Functions:
Coordinate and execute research protocols in coordination with medical, industry, and academic partners Work directly with patients to coordinate study related activities Screen, recruit, and consent patients for participation in research studies Manage multi-site study logistics Maintain exceptionally detailed and complete case report forms, source documentation, and study, regulatory, and patient binders Enter data into remote data capture (RDC) portals Prepare IRB documents; initial application, amendment/modification, AE reporting (sponsor, IRB and DSMB), and continuing review Aid in drafting of protocol, informed consent, and HIPAA Authorization for Research forms Participate in quality control activities such as follow-up on sponsor requests for data clarification and data quality audits Advocate for patient well-being and safety Identify, report, and follow-up on all adverse events and serious adverse events Travel hospitals, clinics, labs, imaging sites to coordinate study activities or accompany patientsOther duties as requested and required to manage research protocols, execute research activities, and ensure patient safety