Description

+ Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.

+ Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.

+ Coordinate collection of study specimens and processing.

+ Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.

+ Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed.

+ Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with spon...