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Clinical Trials Coordinator

2 months ago

Stanford CA, United States Stanford University Full time

Position Overview:
The Clinical Trials Coordinator is tasked with the comprehensive oversight and execution of designated research protocols, ensuring both efficiency and adherence to regulatory standards.

This role involves collaboration with a clinical trials research team and requires reporting to various Principal Investigators engaged in clinical studies.

Key Responsibilities:
- Prepare initial study documentation for Institutional Review Board (IRB) submission, ensuring compliance with all applicable regulations.
- Advise the IRB on protocol amendments and manage annual protocol renewals.
- Recruit, screen, and assist in the informed consent process for study participants, adhering to good clinical practice guidelines.
- Collect, document, and maintain comprehensive data files in accordance with HIPAA regulations.
- Participate in data retrieval, reporting, and preparation of files and Case Report Forms for various studies.

The successful candidate will engage with participants by scheduling diagnostic and research evaluation visits, conducting study-related assessments, including blood sample collection, processing, and shipment.

Additional Duties:
- Maintain accountability for study drugs and ensure adequate supplies and equipment are available.
- Oversee participant compliance with study protocols, gathering information regarding any changes in medications or adverse events, and promptly reporting findings to physicians for documentation in medical records.
- Report all serious adverse events to investigators, sponsors, and the IRB in a timely manner, safeguarding the rights, safety, and well-being of human subjects involved in clinical trials.

Qualifications:
- Education: A two-year college degree with two years of relevant experience, or a Bachelor's degree in a related field, or an equivalent combination of education and experience.

Knowledge, Skills, and Abilities:
- Strong interpersonal skills and proficiency in Microsoft Office.
- Familiarity with medical terminology is essential.

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, along with the ability to lift and carry objects weighing up to 40 pounds.

Working Conditions:
- Flexibility to work occasional evenings and weekends may be necessary.

Work Standards:
- Demonstrates the ability to collaborate effectively with colleagues and external organizations, promoting a culture of safety and responsibility.

The expected pay range for this position is $31.73 to $36.54 per hour, reflecting Stanford University's commitment to providing competitive compensation based on various factors.

Stanford University is an equal opportunity and affirmative action employer, committed to fostering a diverse and inclusive workplace.