What are the responsibilities and job description for the CLINICAL RESEARCH COORDINATOR position at Florida Cancer Affiliates?
Overview :
Florida Cancer Affiliates is looking for a
F / T, Clinical Research Coordinator to join our team !
This position will support the Ocala offices in Ocala, Florida.
Why work for us?
We offer our employees a competitive benefits package that includes Medical, Dental, Vision, Life Insurance, Short-term and Long-term disability coverage, a generous PTO program, a 401k plan that comes with a company match, a Wellness program that rewards you practicing a healthy lifestyle, and lots of other great perks such as Tuition Reimbursement, an Employee Assistance program and discounts on some of your favorite retailers
Responsible for supporting the management and coordination of tasks for multiple clinical research studies to include screening patients for eligibility and participates in the subjects study visits and required activities per protocol. Duties include but not limited to assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, perform ongoing assessments and documentation in collaboration with physicians and other providers, and participation in required training and education, Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.
Responsibilities :
- Screens potential patients for protocol eligibility.
- Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials.
- Assists with patient care in compliance with protocol requirements.
- May disburse investigational drug and maintain investigational drug accountability.
- Participates in data collection, entry, and reporting for the subjects. In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
- Participates in required training and education programs as well as monitoring and auditing activities. May work directly with sponsors. May participate in scheduling monitoring and auditing visits, as well as interact with the monitors / auditors while onsite. Assists with collection and maintenance of regulatory documents in accordance with USOR SOPs and applicable regulations. May assist in the packing and shipping of lab specimens to central vendors.
- May be required to complete Hazmat and / or IATA training.
Qualifications :