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Clinical Research Associate for Sleep Medicine

2 months ago

Stanford, California, United States Stanford University Full time

Position Overview:
Stanford University's Division of Sleep Medicine is seeking a Clinical Research Associate to manage responsibilities related to the acquisition of clinical data and the orchestration of clinical trials.

The Mignot laboratory, in collaboration with the Center for Narcolepsy, integrates fundamental molecular research with both translational and clinical studies.

This role will operate under the guidance of the senior clinical research coordinator and will engage with a team of clinical research coordinators, taking the lead on moderately complex components of ongoing research initiatives.

Key Responsibilities:
- Act as the primary liaison with research participants, sponsors, and regulatory bodies.
- Oversee studies from initiation to completion.
- Assess participant eligibility and obtain informed consent in accordance with established protocols.
- Assist in the formulation of recruitment strategies.
- Coordinate the collection and processing of study specimens.
- Gather and manage patient and laboratory data for clinical research projects.
- Maintain research project databases, develop flow sheets, and complete necessary study documentation.
- Ensure adherence to research protocols and conduct reviews and audits of case report forms for accuracy against source documents.
- Prepare submissions for regulatory bodies and ensure compliance with institutional review board requirements.

- Assemble study kits for participant visits, monitor scheduling of procedures, and attend sponsor monitoring meetings as the primary contact.
- Supervise expenditures and compliance with study budgets, addressing billing issues in collaboration with finance and management staff.
- Regularly interact with the principal investigator to ensure participant safety and adherence to proper study conduct.
- Ensure accurate documentation and recording of patient and research data in compliance with institutional and regulatory standards.
- Participate in monitoring visits and regulatory audits.

Qualifications:
- Bachelor's degree or equivalent combination of education and experience.
- Valid State of California Certified Phlebotomy Technician I (CPT I) certification.
- Minimum of one year of phlebotomy experience and two years of relevant experience in clinical trial coordination.

Skills and Abilities:
- Strong interpersonal communication skills.
- Proficiency in Microsoft Office applications.
- Familiarity with medical terminology.

Certifications:
- Certification from the Society of Clinical Research Associates or the Association of Clinical Research Professionals is preferred.

Physical Requirements:
- Frequent standing, walking, twisting, bending, and fine motor skills are necessary.
- Occasional sitting, reaching, and desk-based tasks are required, with the ability to lift and carry objects weighing up to 40 pounds.

Working Conditions:
- This position may require occasional evening and weekend hours.

Stanford University is committed to providing equal employment opportunities and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.