Clinical Research Coordinator III - Department of Neurosurgery
Classification Title: Clinical Research Coordinator III Job Description:
Due to program expansion, the Department of Neurosurgery is seeking an experienced Clinical Research Coordinator to join the Endovascular Clinical Research Team. The Clinical Research Coordinator III will be responsible for oversite and conduct of interventional therapeutic trials for patients with complex vascular disorder of the neurovascular system.
Responsibilities to include:
Coordination of relevant care and protocol required testing for subjects enrolled on their assigned trials.
- 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 patients and families on the medical aspects of protocols, testing procedures, visit schedules, and side effects of devices and/or therapeutic drugs.
- Orders protocol tests and communicates these test results to patients and their families.
- Communicates with patients on a regularly scheduled basis and assesses progress, evaluates problems and determines appropriate action or physician consultation as needed.
- Communicates and interacts with family members, physicians, nurses and other health care agencies involved with the patients care and follow-up status.
- 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.
Chart Review & Data Interpretation
- 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. Transcribes clinical data on paper case report forms and/or into OnCore/Epic.
- Identifies possible protocol candidates and confirms patient eligibility for protocol participation by attending patient care conferences/clinics, interviewing prospective participants, and reviewing medical records.
- Assists with the evaluation, interpretation and grading of clinical toxicities noted in the medical record using the grading criteria specified in the protocol.
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 and meetings, staff education, etc. as required and provides in-service education related to assigned protocols to ensure compliance.
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.
IRB and Regulatory:
- Collaborates with IRB manager 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.
- Acts as liaison for institution with clinical trial sponsors involved with protocols.
- Submits 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.
- Coordinates all sample collection, analysis, and shipping for assigned trials.
- Coordinates research sample collection with clinical collection personnel and confirms samples are appropriately labeled following collection.
- Ensures that research samples are processed according to protocol or sponsor requirements.
- Provides mentorship to new Clinical Research Coordinators (CRCs), including in-service training related to endovascular, clinical research, and patient care topics. May be assigned to one-on-one mentorship and training tasks for onboarding and retraining purposes.
- Assists the creation of SOPs, workflows, and metrics. Collaborates with leadership and support staff to implement and change policies and/or procedures.
- Participates in working groups and coordinates internal quality control activities in conjunction with internal Monitors and other related staff.
Minimum Requirements: Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience. Preferred Qualifications:
- Previous clinical research experience
- Master’s Degree in Health Care and/or Basic Sciences and experience and/or training in research preferred;
- Prior experience as a Study Coordinator, Monitor, or Auditor.
- Prior experience working in endovascular clinical trials and working knowledge of investigator initiated studies.
- Extensive experience 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, and others;
- 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.
For consideration, please complete an application and include a cover letter, resume and the names and email addresses of three to five references.
The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
This is a time limited position.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required: Yes
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