Clinical Research Coordinator - Medicine - 140311

About the Role

The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellows and postdocs and 480 staff personnel.

Incumbent coordinates and oversees all aspects of cardiovascular clinical research studies, including study start-up activities, implementation of new protocols at the Cardiovascular Clinical Research Unit (CCRU), participant recruitment, screening, enrollment, retention, follow-up, and study closeout activities. Develops informational, educational, and recruitment materials and serves as a liaison between investigators, sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and multiple UC San Diego departments to facilitate the successful activation and conduct of clinical trials.

Plans, develops, and implements start-up procedures for multiple Phase I-IV pharmaceutical, device, investigator-initiated, and federally funded clinical research studies across cardiovascular subspecialties including interventional cardiology, structural heart disease, electrophysiology, heart failure, cardiac imaging, preventive cardiology, and vascular medicine. Provides operational leadership and coordination for study start-up, activation, maintenance, and regulatory compliance activities while ensuring adherence to institutional policies and state and federal regulations, including FDA, ICH-GCP, HIPAA, and human subject protection requirements.

Provides oversight of day-to-day activities of ongoing clinical trials, including but not limited to study administration, regulatory compliance, study coordination, and documentation for complex cardiovascular clinical research protocols. Develops and implements study-specific workflows and operational procedures to support efficient study execution. Ensures all research activities are conducted in compliance with protocol requirements, sponsor expectations, institutional policies, and applicable regulatory standards. Oversees the quality, integrity, and completeness of clinical and research data and assists other investigators and research staff regarding protocol implementation, regulatory requirements, and study conduct.

Responsible for the development, maintenance, and organization of regulatory and study-related documentation required by sponsors, CROs, federal agencies, and regulatory authorities. Properly perform tasks related to the clinical research protocols conducted within the Cardiovascular Clinical Research Unit and ensure compliance with FDA regulations, Good Clinical Practice (GCP), and institutional requirements. Assists with the development, update, and refinement of standard operating procedures (SOPs) within the CCRU, relevant study management tools, quality assurance processes, and regulatory infrastructure to support the growing cardiovascular clinical research portfolio. Takes initiatives to improve operational efficiency, participant recruitment strategies, regulatory compliance, and study maintenance processes.

Responsible for implementing innovative approaches to patient identification, screening, and enrollment utilizing institutional databases, electronic health records, and clinical trial management systems. Performs and oversees protocol-required procedures and study-related assessments as appropriate. Independently collects, analyzes, and interprets clinical research data for presentations, publications, progress reports, and sponsor deliverables. Assists Principal Investigators with protocol development, grant submissions, scientific manuscripts, regulatory submissions, and study feasibility assessments. Identifies opportunities for new clinical research initiatives and collaborates with investigators, sponsors, and institutional stakeholders to expand the cardiovascular clinical research portfolio.

Provides training and ongoing oversight of the assigned clinical trials projects to the other research coordinators, medical students, fellows, residents, nurses, and other clinical research staff participating in cardiovascular clinical trials. Develops educational materials and conducts training sessions related to regulatory compliance, protocol implementation, research operations, and Good Clinical Practice. Utilizes institutional clinical trial management systems, electronic regulatory platforms as applicable, and research databases, including REDCap, Velos, EPIC, and sponsor-specific electronic data capture systems, to manage study activities, track enrollment, monitor study milestones, maintain regulatory compliance, support coverage analysis requirements, and ensure accurate documentation of participant visits and research procedures.

Responsibilities

• Coordinate and oversee all aspects of cardiovascular clinical research studies, including study start-up, implementation, participant recruitment, screening, enrollment, retention, follow-up, and study closeout activities.
• Develop informational, educational, and recruitment materials and serve as a liaison between investigators, sponsors, CROs, IRBs, and multiple UC San Diego departments.
• Plan, develop, and implement start-up procedures for multiple Phase I-IV pharmaceutical, device, investigator-initiated, and federally funded clinical research studies across various cardiovascular subspecialties.
• Provide operational leadership and coordination for study start-up, activation, maintenance, and regulatory compliance activities.
• Oversee day-to-day activities of ongoing clinical trials, including study administration, regulatory compliance, study coordination, and documentation.
• Develop and implement study-specific workflows and operational procedures to support efficient study execution.
• Ensure compliance with protocol requirements, sponsor expectations, institutional policies, and applicable regulatory standards.
• Oversee the quality, integrity, and completeness of clinical and research data.
• Develop, maintain, and organize regulatory and study-related documentation.
• Perform tasks related to clinical research protocols and ensure compliance with FDA regulations, GCP, and institutional requirements.
• Assist with the development, update, and refinement of SOPs, study management tools, quality assurance processes, and regulatory infrastructure.
• Implement innovative approaches to patient identification, screening, and enrollment.
• Perform and oversee protocol-required procedures and study-related assessments.
• Collect, analyze, and interpret clinical research data for presentations, publications, progress reports, and sponsor deliverables.
• Assist Principal Investigators with protocol development, grant submissions, scientific manuscripts, regulatory submissions, and study feasibility assessments.
• Identify opportunities for new clinical research initiatives and collaborate with stakeholders to expand the cardiovascular clinical research portfolio.
• Provide training and oversight to research coordinators, medical students, fellows, residents, nurses, and other clinical research staff.
• Develop educational materials and conduct training sessions on regulatory compliance, protocol implementation, research operations, and GCP.
• Utilize clinical trial management systems, electronic regulatory platforms, and research databases to manage study activities and ensure accurate documentation.

Requirements

• Strong theoretical knowledge and/or Bachelor's Degree in a social science or basic science such as Biology, Microbiology or a related field and/or an equivalent combination of education and work experience.
• Demonstrated experience in clinical trials research conduction both in drug and device trials.
• Strong knowledge of experimental IND and IDE protocols, data gathering, protocol design and evaluation.
• Demonstrated experience in research protocol start-up procedures, including study feasibility, site qualification, CDA/NDA submission, and IRB submission processes.
• Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.
• Strong knowledge of PI-initiated investigational protocols including protocol design and implementation.
• Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, Clinical Research Unit, academic research institution, and/or a research hospital.
• Experience in providing work direction and assisting supervisor(s) in maintaining an efficient medical research team.
• Strong knowledge of investigational protocols especially within a cardiology clinical research setting (protocol design, writing, implementation, data management, query resolution).
• Demonstrated experience with investigational device, new drug, and registry research protocols to screen patients for eligibility, enrollment, randomization, specimen collection, and orienting research staff.
• Strong experience completing clinical trials case report forms both electronic and hard copy as applicable.
• Experience with creation of case report forms based on study-specific needs.
• Proven ability to find creative and innovative solutions to meet the center's needs.
• Ability to be resourceful and understand the overall nature of work/responsibilities to establish useful resources and University contacts.
• Ability to discern items that can be handled independently and those requiring supervisor attention, including quick determination of subject matter issues and necessary actions.
• Working knowledge of medical and scientific terminology, especially related to cardiovascular medicine.
• Proven ability to problem solve and resolve conflict.
• Excellent ability to organize and prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities.
• Meticulous attention to detail.
• Excellent interpersonal, written, and verbal communication skills to interact with a variety of personalities at all organizational levels.
• Skill at negotiating with various personalities and developing internal and external networks of contacts.
• Excellent phone etiquette skills.
• Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office), and internet browser applications.
• Experience in conducting internet searches.
• Demonstrated administrative experience, skill to coordinate complex activities, and use independent judgment to organize and prioritize office functions.

Preferred Qualifications

• Possess a Clinical Research Coordinator Certificate or Master's Degree.
• Knowledge of cost accounting as applied to both University and Medical Center functions.
• Demonstrated knowledge of medical billing and collections guidelines and procedures.

Special Conditions

• Employment is subject to a criminal background check and pre-employment physical.
• Occasional evenings and weekends may be required.
• Must be able to work various hours and locations based on business needs.

Pay

Annual Full Pay Range: $84,940 - $136,555 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $40.68 - $65.40

Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs.

Schedule

• Days, 8-Hour Shifts, Monday-Friday