Clinical Research Coordinator

Position Summary This position independently coordinates and is accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills. It is responsible for the coordination of research projects from pre-study implementation through study closure. The role includes acquiring specimens; extracting and entering patient data; maintaining complete and accurate subject data and regulatory documentation; and analyzing data per protocol. The coordinator provides administrative and regulatory support—including recruiting, interviewing and scheduling study participants, processing IRB and other regulatory documents—to specific clinical departments in accordance with federal, state, regulatory agency, and institutional requirements. It also mentors and trains lower-level clinical research staff, works on departmental projects, and contributes to change implementation within the department. Position Duties Ensure studies are conducted in accordance with FDA, OHRP, GCP, and institutional guidelines. Review all regulatory requirements to implement appropriate methods, practices, and procedures for all research activities. Complete and submit documents to the appropriate IRB and institutional committees on an ongoing basis. Maintain compliance with current and accurate documentation in the regulatory binders as required by regulations and sponsors. Explain the study purpose, parameters, and requirements to participants in collaboration with the principal investigator. Complete all tasks required by study sponsors and provide regulatory documents to sponsors in a timely manner. Complete case report forms, data entry, and maintain source documentation for all study participants. Track and report adverse events per sponsor and institutional guidelines. Coordinate research monitor visits and respond to all data queries. Coordinate the process for opening new studies and obtain needed background material on proposed research projects. Complete feasibility questionnaires and circulate confidentiality disclosure and trial agreements to the appropriate parties. Create study budgets and work with management to determine financial feasibility and resources needed to conduct the trial. Develop workflow procedures for the study team based on specific protocol. Participate in recruitment and selection of study participants, coordinate informed consent, and ensure inclusion and exclusion criteria are met. Coordinate and schedule various medical procedures/tests as required by the study protocol. Provide study-specific education to participants and families regarding procedures, diary/log documentation, dosage/administration, and disease treatment. Review monthly financial reports, including billing, expenditures, and revenue; maintain inventory levels and initiate requisitions for replacements. Participate in professional development programs to stay current with methodologies, practices, and philosophies relevant to the patient population and research area. Provide training, mentoring, and policy development feedback to the research team. Assist in implementing new policies and procedures across the department and institution, and work on special projects as requested. Perform miscellaneous job-related duties as requested. Job Qualifications Education Bachelor’s degree in a related field (Required). Master’s degree in a related field (Preferred). Experience Three years of clinical trial coordination experience (Required). Special Skills Proven ability to coordinate multiple studies of varying complexity while adhering to regulatory and institutional guidelines (Required). Proven ability to coordinate studies across multiple departments and/or disciplines and/or disease processes (Required). Proven ability to take initiative, be proactive, and use independent judgment to improve research (Required). Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care (Required). Additional Requirements ACRP or SOCRA Clinical Research Certification (Required). Clinical Research Training Certification (Required). Phlebotomy Certification (Preferred). Certification / License / Registry Requirements Certified Clinical Research Associate, Certified Clinical Research Coordinator, Clinical Research Coordinator, or ARCP-CP ACRP Certified Profess (Required). Physical Requirements & Occupational Exposure/Risk Potential Feeling only occasionally. Fine motor skills only occasionally. Hearing constantly. Push/pull occasionally. Reach occasionally. Sit frequently. Stand occasionally. Stoop/crouch/kneel/crawl occasionally. Talk frequently. Walk frequently. Near vision frequently. Far vision frequently. Color discrimination frequently. Use keyboard, mouse and/or computer equipment frequently. Lift up to 35 pounds without assistance occasionally. Occupational exposure/responsibility includes inside office environment, airborne communicable diseases, and bloodborne pathogens or bodily fluid (All applicable). #J-18808-Ljbffr