Clinical Research Coordinator I - Neuromuscular Division

University of Florida•Gainesville, FL

2d•$46,000 - $52,000

About The Position

Join our Neuromuscular Division as a Clinical Research Coordinator I and play a key role in advancing innovative clinical research that improves the lives of patients with neuromuscular disorders. This position supports the coordination and day-to-day management of clinical trials, including participant recruitment, study visits, data collection, regulatory documentation, and collaboration with investigators and multidisciplinary teams. We're looking for a detail-oriented, organized, and motivated individual with strong communication skills and a passion for clinical research. This is an excellent opportunity to contribute to meaningful research while growing your career in a collaborative academic and healthcare environment.

Requirements

Associate's degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.

Nice To Haves

Bachelor's degree in Health Care and/or Basic Sciences
Experience working with databases and/or subject data
Strong interpersonal skills, as well as the ability to work with a broad range of people including investigators, physicians, clinic and hospital staff, sponsors, partners at other institutions
Highly resourceful team-player, with the ability to also be extremely effective, independent, interact professionally, and utilize effective writing and organizational skills
Demonstrate understanding and effective use of Emotional Intelligence strategies and skills
Proven ability to handle confidential information with discretion, be adaptable to various competing demands, and demonstrate the highest level of customer/client service and response
Demonstrate ability to achieve high-performance goals and meet deadlines in a fast-paced environment
Forward-thinking mentality, actively seeking opportunities and proposing creative solutions with strong decision-making capability
Demonstrated ability to establish and maintain effective working relationships with stakeholders and critical staff, both internally and externally, through a variety of communication mediums and venues
Project manager mindset and basic skills including delegation, scheduling, communication, critical thinking, task and quality management, risk management, and flexibility

Responsibilities

Coordination of Protocol Subjects: Responsible for the coordination of relevant care and protocol required testing for subjects enrolled on their assigned trials. This includes educating subjects on the informed consent document, confirming execution, registering/randomizing patients, following subject hospitalizations, clinic/office visits, treatments, and scheduled activities. Ordering protocol tests, communicating results to investigators, providers, subjects, and families. Communicating with subjects regularly to assess progress, evaluate problems, and determine appropriate action or investigator/physician consultation. Communicating and interacting with family members, investigators, physicians, providers, nurses, and other health care agencies. Preparing pre-printed and electronic study orders and information sheets. Communicating with investigational pharmacy staff regarding subject enrollment and ensuring adequate supply of investigational agent. Attending Investigator meetings. Following each subject’s clinical course during inpatient hospitalizations and at clinic visits, confirming protocol-specific tests and procedures are completed within study timelines. Entering and tracking all subject status changes in the Clinical Trials Management System (CTMS).
Chart Review & Data Interpretation: Responsible for the interpretation and collection of medical and clinical data of potential and existing subjects on assigned clinical trials, seeking guidance from more senior members. This includes collecting and interpreting data from medical records (history, diagnosis, pathology, lab, radiology, specialty tests, progress notes, side effects, dose modifications), transcribing clinical data into sponsor-specific case reports. Identifying possible protocol candidates and confirming subject eligibility with the investigator by attending patient care conferences/clinics, interviewing prospective participants, and reviewing medical records. Providing accurate and complete data to study sponsors according to protocol timelines. Protecting subject privacy by maintaining complete case report forms and/or research charts in compliance with privacy laws. Evaluating, interpreting, and grading clinical toxicities using specified grading criteria.
Compliance: Responsible for all compliance with internal and external regulatory and institutional requirements. Attending relevant trainings and providing in-service education. Collaborating with monitors and/or sponsors’ data management units to resolve case report form discrepancies. Answering data queries, monitoring for data delinquencies, and replying to special requests. Participating in internal and external inspections and audits. Directing concerns of protocol violations to PI and/or appropriate treating provider. Collaborating with IRB staff to ensure all regulatory documents are appropriately submitted. Communicating serious adverse events and deviations to the IRB, sponsor, and/or FDA. Acting as a liaison for the institution with clinical trial sponsors and data managers. Working with IRB Specialists to submit continuing review/study closure reports, serious adverse event reports, protocol revisions, and other documents to the IRB within appropriate timelines. Preparing cumulative adverse event tables and deviation reports.
Fiscal: Participating in fiscal audits to ensure compliance with billing procedures. Facilitating the submission of research study orders for all sponsor/study-paid services and maintaining department copies. Recording service dates for all protocol-related study visits.
Laboratory: Responsible for the coordination of all sample collection, analysis, and shipping for assigned trials. Coordinating research sample collection with personnel and confirming appropriate labeling. Adhering to safety and quality policies for handling, processing, disposal, and shipping of biological specimens. Ensuring research samples are processed according to protocol or sponsor requirements. Verifying appropriate storage until shipment. Preparing samples for shipment and shipping in accordance with protocol, local, state, and federal requirements. Obtaining, processing, storing, and shipping clinical samples according to sponsor requirements.