Clinical Research Coordinator Associate

About the role

Stanford University’s Departments of Neurosurgery is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of the department’s clinical research studies and biobanking program. Studies may include gene therapies, drug/device trials, longitudinal natural history studies, and other PI‑initiated projects dealing with pediatric neurosurgery treatments. The CRCA’s primary responsibilities will include recruiting, screening and enrolling subjects; specimen collection, processing, storage and shipment; and assisting with regulatory and financial requirements of the trial(s). We are seeking candidates with excellent written and verbal communication skills and the ability to follow through with specifically assigned deliverables. Some previous wet‑lab experience would be beneficial. There are opportunities for long‑term growth within the team, or the position can be a launching pad for a career in the biomedical sciences. This CRCA position is full‑time, with a preferred commitment of at least two years. CRCAs are expected to be on site up to five days a week and may be required to work occasional evening and weekend hours. Physical requirements frequently involve standing, walking, twisting, bending, stooping, squatting and fine light/fine grasping; occasional sitting, reaching above shoulders, desk‑based computer tasks, telephone use, handwriting, lifting, carrying, pushing and pulling objects up to 40 pounds; rarely kneeling, crawling, climbing ladders, forceful grasping, sorting/filing paperwork or parts, and rarely lifting/carrying/pushing/pulling objects 40 pounds or more.

Responsibilities

• Serve as primary contact with research participants, sponsors, and regulatory agencies.
• Coordinate studies from start‑up through closeout.
• 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 sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.