Clinical Research Coordinator 2 (Fixed-term 2 years)
Stanford University
About this position
Position Description
The Department of Anesthesiology, Perioperative and Pain Medicine, at Stanford University’s School of Medicine, is a world-leading department that offers comprehensive training, perioperative patient care, pain management, and critical care medicine. The department also engages in cutting edge research, encompassing a wide spectrum of programs in basic, translational, clinical, health services and medical education. The Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University is seeking a Clinical Research Coordinator 2 to serve as the operational program manager for the ARPA-H EVIDENT TA1 project, a 24-month, multi-PI, multi-trial clinical research program spanning five PIs across four departments. The position reports primarily to Dr. Boris Heifets (Anesthesiology) and requires strong REDCap and IRB experience, demonstrated cross-team coordination skills, and the ability to independently manage complex, federally funded research operations. At Stanford University School of Medicine, the work we do touches the lives of those today and tomorrow. Through education, research, and health care, the School of Medicine improves health through leadership, diversity, collaborative discoveries, and innovation in health care. Whether working in departments with faculty, or in units that support the school, our staff are a part of teams that propel us on our journey toward the future of medicine and Precision Health. 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. School of Medicine, and the Department of Anesthesia are committed to diversity, equity, and inclusion for its faculty, staff, residents, and postdocs, and fellows. We aim to recruit, support, retain, and promote diversity in our department. For more information on our department, please see our website: https://med.stanford.edu/anesthesia.html Duties include: Serve as primary program manager for the ARPA-H EVIDENT TA1 project, a 24-month multi-PI, multi-trial biomarker study. Coordinate across five PIs and four IRB-approved clinical trials. Develop and maintain cross-trial coordination plans, enrollment tracking, and milestone monitoring tied to ARPA-H deliverables. Oversee and directly coordinate participant data collection visits across all four biometric modalities: immune blood draws, wearable/PSG sleep EEG, actigraphy/GPS, and MRI neuroimaging. Ensure time-locked pre- and post-dosing collection protocols are followed. Maintain REDCap databases and ensure data completeness across all trials. Maintain complete, accurate, and audit-ready study records in compliance with GCP, HIPAA, IRB requirements, and ARPA-H data delivery standards. Ensure integrity of REDCap databases across all four trials. Track and reconcile data completeness metrics for quarterly ARPA-H reporting (enrollment trajectory: N=15, 30, 50, 75, 100, 125, 143 across 24 months). Apply knowledge of GCP, IRB regulations, and clinical operations to monitor and continuously improve cross-trial data collection procedures. Identify and resolve compliance or workflow issues in consultation with the PI and data PIs. Stay current with FDA and ARPA-H guidance, GCP updates, and best practices in psychedelic and psychiatric clinical research. Apply learnings to continuously improve cross-trial data collection protocols and regulatory compliance procedures. Contribute to preparation of ARPA-H deliverable reports, manuscripts, SOPs, and grant applications as needed. Prepare and present data completeness and progress summaries to the PI and multi-PI team. Manage regulatory and administrative infrastructure for EVIDENT TA1: maintain IRB files, consent forms, protocol amendments, and regulatory correspondence. Liaise with Stanford Office of Research, SoM Research Compliance, and the ARPA-H program office. Track vendor contracts, equipment procurement, and budget expenditures. Supervise, train, and mentor junior research coordinators and students supporting data collection across labs. Lead team meetings and prepare meeting minutes. Serve as primary point of contact for all study personnel on protocol questions, scheduling, and data entry procedures. * - Other duties may also be assigned DESIRED QUALIFICATIONS: Strong proficiency with REDCap database management, including database build, data quality monitoring, and multi-trial record management. Demonstrated experience managing IRB submissions, amendments, and regulatory correspondence. Prior experience as a clinical research coordinator on multi-PI or multi-site clinical trials strongly preferred; this position operates across five PIs but reports primarily to Dr. Heifets (Anesthesiology). Experience with FDA regulatory requirements (IND, GCP compliance, protocol deviations) a plus. Experience with psychedelic, psychiatric, or neurological clinical research preferred. Familiarity with ARPA-H, NIH, or other federal research contracts preferred. Society of Clinical Research Associates (SoCRA) or ACRP certification preferred. Master’s degree in a health-related or life science field preferred. EDUCATION & EXPERIENCE (REQUIRED): Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Strong interpersonal skills Proficiency with Microsoft Office and database applications. Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. Knowledge of medical terminology. CERTIFICATIONS & LICENSES: Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver’s License. PHYSICAL REQUIREMENTS*: Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. * - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. May require extended or unusual work hours based on research requirements and business needs. WORK STANDARDS Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu. The expected pay range for this position is $86,248 to $100,158 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process. Additional Information Schedule: Full-time Job Code: 4923 Employee Status: Fixed-Term Grade: H Requisition ID: 108681 Work Arrangement : Hybrid Eligible
Qualifications
DESIRED QUALIFICATIONS: Strong proficiency with REDCap database management, including database build, data quality monitoring, and multi-trial record management. Demonstrated experience managing IRB submissions, amendments, and regulatory correspondence. Prior experience as a clinical research coordinator on multi-PI or multi-site clinical trials strongly preferred; this position operates across five PIs but reports primarily to Dr. Heifets (Anesthesiology). Experience with FDA regulatory requirements (IND, GCP compliance, protocol deviations) a plus. Experience with psychedelic, psychiatric, or neurological clinical research preferred. Familiarity with ARPA-H, NIH, or other federal research contracts preferred. Society of Clinical Research Associates (SoCRA) or ACRP certification preferred. Master’s degree in a health-related or life science field preferred. EDUCATION & EXPERIENCE (REQUIRED): Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Strong interpersonal skills Proficiency with Microsoft Office and database applications. Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. Knowledge of medical terminology. CERTIFICATIONS & LICENSES: Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver’s License. PHYSICAL REQUIREMENTS*: Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. * - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. May require extended or unusual work hours based on research requirements and business needs. WORK STANDARDS Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu. The expected pay range for this position is $86,248 to $100,158 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.
Job Location
🔍 School of Medicine, Stanford, California, United States