Dr. Emmanuel Mignot’s laboratory within the Division of Sleep Medicine in the Department of Psychiatry & Behavioral Sciences is seeking a Clinical Research Coordinator Associate to perform duties related to the collection of clinical data and the coordination of clinical studies. The Mignot laboratory in connection with the Center for Narcolepsy combines basic molecular research with translational and clinical research. This position will work under the supervision of the senior clinical research coordinator and will collaborate with a team of clinical research coordinators while taking the lead role and coordinating moderately complex aspects of an ongoing study. This position will be located at the Stanford Redwood City campus and is hybrid eligible. This position is a 1-year fixed term role.
DESIRED QUALIFICATIONS:
Bachelor’s degree
2 years of related experience in clinical trials
PHYSICAL REQUIREMENTS*:
- Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
WORKING CONDITIONS:
Occasional evening and weekend hours.
Core Duties:
- 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.
- Participate in monitor visits and regulatory audits.
Minimum Education and Experience
Two-year college degree and two years related work experience or a bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.
Knowledge, Skills and Abilities:
- Strong interpersonal skills.
- Proficiency with Microsoft Office.
- Knowledge of medical terminology.
Certificates and Licenses Required
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
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Drivers License Requirements
Must possess and maintain a valid California non-commercial Class C Driver's License.
Ability to drive day or night.
When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.