Clinical Research Coordinator Associate (Fixed-term 1 year)

Stanford University; Palo Alto (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Stanford University is seeking a Clinical Research Coordinator Associate (CRCA) to support two ongoing clinical trials in the Department of Anesthesiology. The role involves coordinating clinical care, patient recruitment, follow-up, and regulatory communications with IRBs, the FDA, and the DEA, under academic mentorship from the principal investigator.

This fixed-term 1-year position requires collaboration with a multidisciplinary team across Stanford and UCSF, with opportunity for scholarly

Qualifications

• Strong interpersonal skills required.
• Proficiency with Microsoft Office tools.
• Knowledge of medical terminology is preferred.

Responsibilities

• Serve as primary contact with participants, sponsors, and regulatory agencies; coordinate studies from start-up through closeout.
• Determine eligibility and obtain consent from study participants; assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data; maintain study databases and case report forms.
• Ensure compliance with protocols; prepare regulatory submissions and IRB renewals.
• Assemble study kits, monitor scheduling and charges, and attend monitoring meetings with sponsors.
• Monitor expenditures and adherence to study budgets; resolve billing issues with finance.
• Interact with the principal investigator to ensure patient safety and proper study conduct.
• Ensure documentation and recording of data per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.

Skills

Strong interpersonal skills

Proficiency with Microsoft Office

Knowledge of medical terminology

Education

Two-year college degree or bachelor's degree in a related field

Tools

Microsoft Office

Job description

Join a dynamic, highly collaborative research group as a clinical research coordinator. This job involves coordinating clinical care, patient recruitment, follow-up, and managing communications with IRBs, the FDA and the DEA. Our group is currently running two clinical trials, and collaborating with several other research groups on other trials. Direction and academic mentorship will be provided by the principal investigator, and opportunities for academic contributions are certainly available.

Do you think rapid-acting treatments for psychiatric disorders are the future of applied neuroscience? We are looking for a highly motivated and personable Clinical Research Coordinator Associate (CRCA) - Fixed-term 1 year to join the research group of Dr. Boris Heifets MD PhD in the Department of Anesthesiology at Stanford University School of Medicine. Dr. Heifets' research group conducts both basic neuroscience and clinical research aimed at understanding how an emerging group of therapies, like ketamine and psilocybin, might function in the brain and how they could be used to outcomes for patient undergoing surgery and in chronic pain. This is an excellent opportunity to become a key player of a team thriving to make impactful contributions to the practice of perioperative medicine and pain management.

You will be responsible for day-to-day operations of two or more clinical studies, working with a highly collaborative team that includes Principal and co-investigators, fellow, residents, research nurse, medical students, and colleagues in the Psychiatry department at Stanford and UCSF, and Stanford's Pain Medicine Division. Stanford University, located between San Francisco and San Jose in the heart of California's Silicon Valley, is one of the world's leading teaching and research universities. Since its opening in 1891, Stanford has been dedicated to finding solutions to big challenges and to preparing students for leadership in a complex world.

Supporting that mission is a staff of more than 10,000, which is rooted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends and benefits that increase financial stability and promote healthy, fulfilling lives. An award- winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers.

Responsibilities

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.