Location: Jacksonville, Florida
Academic / Research
Oncology Clinical Research Coordinator
Jacksonville, FL, United States
The Clinical Research Coordinator coordinates, implements and completes clinical research studies or clinical trials by assisting with IRB submissions, assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining study records, interfacing with study sponsors, participation in sponsor study monitoring visits.
Job Details include, but not limited to:
- Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned.
- Supporting NCCBD's NCORP: NCI Community Oncology Research Program across the Nemours enterprise.
- Develops source documents, parental permission, and assent documents for submission to IRB. Coordinates IRB submissions for assigned studies, maintains regulatory documents during conduct of study; develops and uses study participant and family teaching tools for study purposes; interfaces with representatives of sponsoring agencies.
- Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants following study protocols; develops strategies to assure compliance of study participants with protocol requirements.
- Performs clinical data gathering and measurements and monitoring of data integrity, including data completeness, accuracy, and quality. Maintains study databases
- Participates in training nursing and ancillary study staff for study purposes; recruits, screens and enrolls sufficient number of study participants in conformance with protocol requirements.
- Assists in identifying, reporting and following-up on Serious Adverse Events.
- Assists in the maintenance of study medication accountability records; prepares clinical specimens for shipment to central laboratories.
- Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
Additional Skills and Abilities:
- General knowledge of office and clinic practices and organization policies
- Strong understanding of medical terminology, anatomy, physiology, clinical medicine, surgery, diagnostic tests, radiology, pathology, pharmacology, hematology, and oncology
- Ability to read and interpret various documents and manuals such as protocols, informed consents, and regulatory documentation
- Familiarity with the Code of Federal Regulations as they pertain to human subject clinical research
- Proficiency in computer software applications, including Microsoft Excel, and Microsoft Word and internet programs
- Excellent reading and writing skills
- Ability to work independently, problem solve, and deal with a variety of situations; detail-oriented
- Familiar with database programs and data entry
- Ability to communicate both effectively and professionally with location staff and patients
- Ability to maintain strict confidentiality of practice and/or patient information
- Bachelor's degree required
- Hematology or Oncology: 1 year
- Clinical Research: 2 years (Preferred)
- Clinical Research Coordinator: 1 year (Preferred)
Compensation and Benefits:
- Salary is commensurate with experience and qualifications
Nemours is an "EEO Employer" and "Drug Free Workplace"
Job Type: Full-time
- Retirement benefits or accounts
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance