What are the responsibilities and job description for the Clinical Research Coordinator position at Stanford University School of Medicine?
The Biobehavioral Pediatric Pain (BPP) Laboratory in the Department of Anesthesiology, Perioperative and Pain Medicine is seeking a full-time Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical research studies. The lab primarily focuses on the assessment and treatment of psychological aspects and neural underpinnings of chronic pain in children and adolescents. The CRCA will coordinate moderately complex aspects of one or more clinical studies and will work under close direction of the principal investigator and/or lab manager. The CRCA will be primarily involved with BPP but will also interact with other clinicians and researchers across labs and settings. Please see our website for more information about our lab.
Responsibilities
- Serve as the primary contact for research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
- Determine/make decisions regarding eligibility for participants, study protocols, and compliance issues based on IRB and other regulatory agencies.
- Manage data, evaluate study effectiveness and make recommendations to the PI as needed. Ensure data accuracy and completeness.
- Determine participant eligibility and obtain informed consent from study participants in accordance with study protocol. Assist in developing, evaluating and revising recruitment strategies to increase participant enrollment as needed.
- Coordinate collection, processing and analysis of study specimens and data.
- Manage research project databases, develop flow sheets and other study related documents, and ensure the accurate completion of study documents/case report forms. Independently collect and manage patient tracking tools and study documents. Must be experienced and able to design and implement study documents and understand Stanford clinical trial study requirements/regulations to accurately handle/process informed consents, study questionnaires, and screening tools.
- Ensure compliance with research protocols. Prepare regulatory submissions and ensure IRB renewals are completed in a timely fashion. Serve as a resource to other team members to maintain/monitor privacy of data as well as providing training on regulatory process/requirements as needed. Responsible for reporting protocol deviations to the IRB; notify PI of any issues regarding privacy for further action.
- Assemble study kits, monitor scheduling of procedures/study visits, coordinate documents, and attend monitoring meetings with sponsors. May supervise work of students to assemble study kits and scheduling of study participants; must be able to lead project meetings, communicate study progress, and present data (meetings are not with participants).
- Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.Develop and provide status reports to PI; propose solutions to any problem related to safety. Monitor participants for any adverse events related to participant health status and reports to PI; provide reports related to recruitment, quarterly reports required by IRB or funding source.
- 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.
Qualifications
- Knowledge of principles of clinical research (Good Clinical Practice HIPAA) and federal regulations.
- Ability to effectively work in a fast-paced environment with multiple projects and timelines.
- Familiarity with IRB guidelines and regulations.
- Previous experience with REDCap/Qualtrics/SPSS or other related database/statistics applications.
- Previous experience working with children and families.
- Experience/knowledge of psychology research.
- Minimum of one-year related experience.
