Cancer Specialists LLC
Coordinates daily clinical trial activities across multiple research projects and ensures trial protocol compliance. The role involves patient recruitment, screening, consenting, enrollment, clinical documentation, and collaboration with clinical site staff, sponsors, CROs, IRBs, and study participants. This position also provides patient and staff education on trial concepts and requirements and may travel outside the home clinic for coverage when needed.
Key Responsibilities
- • Review and develop a familiarity with trial protocol including but not limited to study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protection
- • Serve as a resource and “expert” for clinical staff and patients regarding clinical trial questions
- • Ensure compliance with research protocols by providing ongoing quality control audits
- • Provides CRC coverage to all CSNF clinics as assigned by manager or team lead.
- • Strong interpersonal and communication skills to effectively collaborate with clinic site staff and research staff.
- • Recruit and screen potential study participants and perform intake assessments for assigned clinical trials in accordance with trial protocol
- • Obtain informed consent in accordance to the Code of Federal Regulations (45 CFR part 46)
- • Coordinate all study visits and assist treating physician with completion of trial activities including but not limited to: schedule participant visits, coordinate participant travel and meals, participant dosing and observation, scheduling and other evaluations, adverse event monitoring, vitals collection, and IVRS management
- • Collect, process, and ship specimens
- • Collaborate with the research pharmacist to perform drug accountability, compliance, and dosing
- • Educate clinical staff regarding study drug administration requirements, including required pre-medications, order of administration, monitoring time points, and the need for infusion start/stop times
- • All other duties as assigned.
Required
- • Bachelor’s degree in science or health related field
- • 2+ years of work as a clinical research coordinator in an oncology setting
- • Strong interpersonal and communication skills to effectively collaborate with clinic site staff and research staff
Preferred
- • BSN, PharmD, MD, or PhD preferred
Benefits & Perks
- • Salary is commensurate with experience and qualifications.
Cancer Specialists of North Florida is recruiting a Clinical Research Coordinator for our busy Specialty Practice. This position will travel outside of their home clinic when needed for coverage. The Clinical Research Coordinator (CRC) will facilitate timely coordination of daily clinical trial activities across multiple research projects and ensure trial protocol compliance. The CRC is responsible for recruitment, screening, consenting, enrollment, and clinical documentation of patients in clinical trials as well as ensuring protocol compliance. The CRC will provide education to patients and staff about trial concepts and requirements for participation. The CRC will work collaboratively with the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure execution of the clinical trial in accordance with the trial protocol, Food and Drug Administration (FDA), Good Clinical Practice (GCP) guidelines, and applicable state and local regulations. In addition to this, the CRC assists the research team, physicians and manager with any additional projects requested. Essential duties and responsibilities include the following:
- Review and develop a familiarity with trial protocol including but not limited to study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protection
- Serve as a resource and “expert” for clinical staff and patients regarding clinical trial questions
- Ensure compliance with research protocols by providing ongoing quality control audits
- Provides CRC coverage to all CSNF clinics as assigned by manager or team lead.
- Strong interpersonal and communication skills to effectively collaborate with clinic site staff and research staff.
- Recruit and screen potential study participants and perform intake assessments for assigned clinical trials in accordance with trial protocol
- Obtain informed consent in accordance to the Code of Federal Regulations (45 CFR part 46)
- Coordinate all study visits and assist treating physician with completion of trial activities including but not limited to: schedule participant visits, coordinate participant travel and meals, participant dosing and observation, scheduling and other evaluations, adverse event monitoring, vitals collection, and IVRS management
- Collect, process, and ship specimens
- Collaborate with the research pharmacist to perform drug accountability, compliance, and dosing
- Educate clinical staff regarding study drug administration requirements, including required pre-medications, order of administration, monitoring time points, and the need for infusion start/stop times
- All other duties as assigned.
Full Time M-F position
Education and Experience:
- Bachelor’s degree in science or health related field; BSN, PharmD, MD, or PhD preferred
- 2+ years of work as a clinical research coordinator in an oncology setting
Compensation and Benefits:
- Salary is commensurate with experience and qualifications.
Cancer Specialists of North Florida is an "EEO Employer” and “Drug Free Workplace”
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