Clinical Research Coordinator

Clinical Research Coordinator IJoin 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.Coordination of Protocol SubjectsEducates subjects on topics related to the informed consent document and confirms that informed consent documents are appropriately executed, registers and/or randomizes patients with appropriate sponsorFollows subject hospitalizations, clinic/office visits, treatments and scheduled activitiesOrders protocol tests and communicate these test results to investigators, treating providers, subjects, and their families, as applicableCommunicates with subjects on a regularly scheduled basis and assesses progress, evaluates problems and determines appropriate action or investigator/physician consultation as neededCommunicates and interacts with family members, investigators, physicians, providers, nurses and other health care agencies involved with the subject's care and follow-up statusPrepares pre-printed and electronic study orders and study information sheets and secures appropriate approvals as requiredCommunicates with investigational pharmacy staff regarding subject enrollment, ensuring an adequate supply of investigational agent is available prior to subject appointmentsAttends Investigator meetings and represents the University of Florida in a professional mannerFollows each subject's clinical course during inpatient hospitalizations and at clinic visits, confirming that all protocol-specific tests and procedures are completed within study timelinesEnters and tracks all subject status changes in the Clinical Trials Management System (CTMS)Chart Review & Data InterpretationCollects and interprets—with guidance from more senior Study Coordinators, their mentor, Leader, and/or Unit Manager—data from medical records, including medical history, diagnosis, pathology, laboratory, radiology, specialty test results, progress notes, reported side effects or adverse reactions and dose modificationsTranscribes clinical data into sponsor-specific case reportIdentifies possible protocol candidates and confirms subject eligibility with the investigator for protocol participation by attending patient care conferences/clinics, interviewing prospective participants, and reviewing medical recordsProvides accurate and complete data to study sponsors according to protocol timelinesProtects subject privacy by maintaining complete case report forms and/or research charts in compliance with privacy lawsWith guidance from more senior Study Coordinators, their mentor, Leader, and/or Unit Manager, as needed, evaluates, interprets, and grades clinical toxicities noted in the medical record and subject diaries using the grading criteria specified in the protocolComplianceMonitors Audits and QACollaborates with monitors and/or with sponsors' data management units to resolve case report form discrepanciesAnswers data queries, monitors for data delinquencies, and replies to special requests as necessaryParticipates in internal and external inspections and audits of subject medical records to ensure compliance with the protocolDirects concerns of protocol violations to PI and/or appropriate treating providerIRB and RegulatoryCollaborates with internal and external IRB staff to ensure all regulatory documents are appropriately submittedWith guidance from more senior Study Coordinators, their mentor, Leader, and/or Unit Manager, as needed, communicates serious adverse events and both planned and unplanned subject deviations to the IRB, sponsor, and/or FDA according to established reporting requirementsActs as liaison for institution with clinical trial sponsors, and data managers involved with protocolsWorks with internal IRB Specialists to submit continuing review/study closure reports, serious adverse event reports, protocol revisions and other documents to the IRB within appropriate timelines to prevent project expiration or sponsor deficienciesPrepares cumulative adverse event tables and deviation reports as required for continuing review or closure reportsFiscalParticipates in fiscal audits to ensure compliance with established billing proceduresFacilitates the submission of research study orders for all sponsor/study-paid services and maintains department copies of all submitted ordersRecords the service dates for all protocol-related study visits using the appropriate tracking log or database systemLaboratoryCoordinates research sample collection with clinical and/or research collection personnel and confirms samples are appropriately labeled following collectionAdheres to pertinent safety and quality policies and procedures for the handling, processing, disposal, and shipping of biological specimensEnsures that research samples are processed according to protocol or sponsor requirementsVerifies that research samples are stored appropriately until shipmentPrepares samples for shipment as required by the protocol and ship samples in accordance with protocol, local, state and federal requirementsObtains, processes, stores and ships clinical samples according to sponsor requirementsExpected Salary: 46,000 - 52,000 annuallyRequired Qualifications: 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.Preferred: The ideal candidate will possess: 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 flexibilitySpecial Instructions to Applicants: To be considered for this position, please upload the following: Cover letter Resume Names and Contact information of three (3) professional references. Application must be submitted by 11:55 p.m. (ET) of the posting end date. This is a time-limited position.Health Assessment Required: Yes