Clinical Research Coordinator Associate, Pediatric Surgery (Hybrid Opportunity)

Stanford University•Stanford, CA

48d•$35 - $40•Hybrid

About The Position

This position will be based on the Stanford campus and is a hybrid of working on-site and working from home, subject to operational need. The Department of Surgery, Division of Pediatric Surgery at the Stanford University School of Medicine is seeking a Clinical Research Coordinator Associate (CRCA) to perform work related to the support of clinical studies. The CRCA will be primarily responsible for coordinating studies from start-up through close-out. This includes, but is not limited to, following study related workflows, conducting patient recruitment, following consent procedures, assisting with sample collection and processing, and adhering to IRB and Stanford's institutional regulations. The CRCA will work under close direction of the principal investigator and study managers/supervisors as well as work collaboratively with research study staff, clinicians, and the staff of Stanford clinics, hospitals, and departments. This role also requires assisting study staff with IRB requests, maintaining documentation and databases, extracting data, and preparing documentation for audits. As the division and studies within grow, other duties may be assigned.

Requirements

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.
Strong interpersonal skills.
Proficiency with Microsoft Office.
Knowledge of medical terminology.

Nice To Haves

Bachelor's Degree in science or health related field is preferred.
Background in clinical research preferred.
Comfortable working with patients and guardians during the research consenting process.
Ability to assess patient's interest and willingness to consent.
Experience with electronic medical records and databases containing public health information (PHI).
Strong knowledge of medical terminology.
Excellent communication skills, energetic, motivated and work well both autonomously and as a team.
Possess a high level of initiative. Willingness to take on new projects and tasks, and want to grow within the division.
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred but not required. Stanford will provide training in HIPAA, CITI, and any other related clinical research training required to perform study duties and meet IRB and Stanford's institutional requirements.

Responsibilities

Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out.
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.
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.
Other duties may also be assigned.