| Job Description: |
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.
More about this Opportunity
Coordination of Protocol Subjects
- Incumbent is responsible for the coordination of relevant care and protocol required testing for subjects enrolled on their assigned trials.
This includes the following tasks:
- Educates 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 sponsor
- Follows subject hospitalizations, clinic/office visits, treatments and scheduled activities
- Orders protocol tests and communicate these test results to investigators, treating providers, subjects, and their families, as applicable
- Communicates with subjects on a regularly scheduled basis and assesses progress, evaluates problems and determines appropriate action or investigator/physician consultation as needed
- Communicates and interacts with family members, investigators, physicians, providers, nurses and other health care agencies involved with the subject’s care and follow-up status
- Prepares pre-printed and electronic study orders and study information sheets and secures appropriate approvals as required
- Communicates with investigational pharmacy staff regarding subject enrollment, ensuring an adequate supply of investigational agent is available prior to subject appointments
- Attends Investigator meetings and represents the University of Florida in a professional manner
- Follows each subject’s clinical course during inpatient hospitalizations and at clinic visits, confirming that all protocol-specific tests and procedures are completed within study timelines
- Enters and tracks all subject status changes in the Clinical Trials Management System (CTMS)
Chart Review & Data Interpretation
- Incumbent is responsible for the interpretation and collection of medical and clinical data of potential and existing subjects on assigned clinical trials, seeking guidance and assistance from more senior members of their Unit in confirming their assessments.
This includes the following tasks:
- Collects 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 modifications
- Transcribes clinical data into sponsor-specific case report
- Identifies 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 records
- Provides accurate and complete data to study sponsors according to protocol timelines
- Protects subject privacy by maintaining complete case report forms and/or research charts in compliance with privacy laws
- With 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 protocol
Compliance
- Incumbent is responsible for all compliance with all internal and external regulatory and institutional requirements related to the trials assigned to them. Responsible for attends all relevant trainings as required, and provides in-service education related to assigned protocols to ensure compliance.
Overall compliance responsibilities can be broken out into the following sections and tasks:
- Monitor Audits and QA
- Collaborates with monitors and/or with sponsors’ data management units to resolve case report form discrepancies
- Answers data queries, monitors for data delinquencies, and replies to special requests as necessary
- Participates in internal and external inspections and audits of subject medical records to ensure compliance with the protocol
- Directs concerns of protocol violations to PI and/or appropriate treating provider. IRB and Regulatory
- Collaborates with internal and external IRB staff to ensure all regulatory documents are appropriately submitted
- With 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 requirements
- Acts as liaison for institution with clinical trial sponsors, and data managers involved with protocols
- Works 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 deficiencies
- Prepares cumulative adverse event tables and deviation reports as required for continuing review or closure reports
Fiscal
- Participates in fiscal audits to ensure compliance with established billing procedures
- Facilitates the submission of research study orders for all sponsor/study-paid services and maintains department copies of all submitted orders
- Records the service dates for all protocol-related study visits using the appropriate tracking log or database system
Laboratory
Incumbent is responsible for the coordination of all sample collection, analysis, and shipping for assigned trials, includes the following tasks (may be delegated to CRAs as appropriate):
- Coordinates research sample collection with clinical and/or research collection personnel and confirms samples are appropriately labeled following collection
- Adheres to pertinent safety and quality policies and procedures for the handling, processing, disposal, and shipping of biological specimens
- Ensures that research samples are processed according to protocol or sponsor requirements
- Verifies that research samples are stored appropriately until shipment
- Prepares samples for shipment as required by the protocol and ship samples in accordance with protocol, local, state and federal requirements
- Obtains, processes, stores and ships clinical samples according to sponsor requirements
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| 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 flexibility
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