The coordinator manages daily operations of clinical trials for the Multiple Sclerosis section, including regulatory submissions and subject coordination. They are also responsible for collecting clinical data, ensuring IRB compliance, and coordinating biological sample processing and shipping.
Requirements summary
Requires a bachelor's degree in a relevant field and at least two years of relevant experience, preferably in human subject research. Candidates should be proficient in Microsoft Office and possess strong organizational and interpersonal skills.
Bachelor’s degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Job Description
The Multiple Sclerosis (MS) and Neuroimmunology Section in the Department of Neurology is seeking passionate clinical research coordinators who want to further the mission of research and pursue the prevention and treatment of MS and other immune-mediated disorders of the central nervous system (CNS).
If you have 2 years or more of human subject research experience and you are detailed-oriented, motivated, passionate about clinical research, and enjoy working collaboratively to meet shared goals and objectives, we hope you apply!
We are currently involved in multiple multicentered drug trials for Multiple Sclerosis.
The Clinical Research Coordinator II is responsible for the daily operations of clinical trial studies run by the MS Section.
Responsible for ensuring that all required regulatory documentation is completed and submitted as appropriate for all research/clinical trial activity which includes, but is not limited to, new submissions, continuing reviews, and revisions through the University of Florida Health Professions IRB and a central IRB.
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.
Educates subjects and families on the medical aspects of protocols, testing procedures, visit schedules, and side effects of chemotherapy and/or other therapeutic drugs.
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 patients 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 investigation 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) OnCore.
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. This includes the following tasks:
Collects and interprets 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. Transcribe clinical data into sponsor-specific case report forms, delegating to Clinical Research Assistants (CRA) as appropriate.
Identifies possible protocol candidates and confirms patient 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.
Evaluates, interprets and grades clinical toxicities noted in the medical record and subject diaries using the grading criteria specified in the protocol.
Provides guidance and assistance to Study Coordinator Is in the assessment of clinical data.
Compliance
Incumbent is responsible for all compliance with all internal and external regulatory and institutional requirements related to the trials assigned to them. 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 reports from 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
Collaborate with internal and external IRB staff to ensure all regulatory documents are appropriately submitted.
Communicates serious adverse events and both planned and unplanned subject deviations to the IRB, sponsor, and/or FDA according to established reporting requirements.
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.
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.
Ensure 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.
Expected Salary
$53,000 - $65,000 Annually
Required Qualifications
Bachelor’s degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Preferred: 2 years or more of human subject research
Experience working with databases and/or subject data;
Proficiency with Microsoft Office suite, particularly Outlook, Excel, Word;
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;
Demonstrate 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.
Special Instructions to Applicants
In order to be considered, you must upload your cover letter and resume.
