Clinical Research Coordinator - Medicine - 140311

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 refine 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.

• 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 and site qualification procedures, CDA/NDA submission, local and central/commercial 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 with cardiology clinical research setting (protocol design, protocol writing and protocol implementation, data management, query resolution).

• Demonstrated experience with investigational device and investigational new drug and registry research protocol in order to screen patients for eligibility, enrollment, randomization to the initiate treatment plan, specimen collection, and orient participating physicians, nurses and other relevant research staff.

• Strong experience completing clinical trials case report both electronic and hard copy as applicable. Experience with creation of the case report forms based on the specific needs of the study.

• Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to 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 which require attention of supervisor, including ability to quickly determine subject matter issues and necessary action to be taken in a timely manner.

• Working knowledge of medical and scientific terminology especially related to the cardiovascular medicine.

• Proven ability to problem solve and resolve conflict.

• Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.

• Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network 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 searches on the internet.

• Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

• 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.

• 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.