Clinical Research Coordinator II
- Savannah, GA
- CH - Oncology Clinical Trials
- Part Time Benefitted - Days
- Req #: 3562-12191
Summary
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Position Summary
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The Clinical Research Coordinator II (CRC-II) is responsible for the coordination of all day-to-day clinical research activities with minimal supervision. The CRC-II is assigned more complex studies, including but not limited to Phase II and Phase III therapeutic clinical trials for various types or stages of cancer. The CRC-II is responsible for coordinating multiple clinical trials simultaneously and ensures full compliance with each research protocol adhering to applicable federal regulations, Good Clinical Practice (GCP), SJ/C Policies & Procedures, and Institutional Review Board (IRB) requirements. The CRC-II works with clinical investigators to recruit diverse research participants representative of the site’s catchment area. Key tasks of the CRC-II include but are not limited to the following: obtains informed consent, confirms participant eligibility, coordinates participant schedules to comply with research protocol requirements, and ensures the participant’s overall care is coordinated per the parameters set forth in the research protocol. The CRC-II also collects and processes blood or other biospecimens, performs EKGs or other clinical assessments as required by the research study, and collects & reports participant data. The CRC-II will participate in review of prospective clinical research studies and takes the lead as the primary contact for study selection activities. The CRC-II maintains open communication with the other members of the research team and demonstrates the ability to function autonomously as well as part of a team.
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Education
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Associate's in Healthcare or Social Sciences - Required
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Bachelor's of Science in Nursing - Preferred
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Experience
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1-2 Years Clinical Research experience or 3 Years Nursing experience - Required
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2-3 Years Oncology experience - Preferred
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License & Certification
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Nurse candidates: Professional License with State of Practice - Required
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CCRC, CCRP, or OCN certification required within 18 months of hire or upon eligibility.
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Core Job Functions
- Adherence to Ethical Standards: Promotes ongoing compliance with the key ethical concepts of research, including respect for individuals, beneficence, and justice. Adheres to federal and institutional regulations and policies & procedures related to clinical research. Maintains awareness of what constitutes research misconduct and adheres to federal and institutional requirements for reporting research misconduct.
- Protocol Compliance: Communicates with the interdisciplinary team to ensure protocol compliance and timeliness of protocol-related procedures. Contributes to discussions regarding feasibility of protocol implementation with a specific focus on clinical issues, available resources, study coordination, patient safety, and data quality. Identifies facilitators and barriers to protocol compliance. Promptly reports instances of protocol noncompliance and assists with writing corrective and preventative action plans. Maintains assigned study folders ensuring the use of the current version of the IRB approved protocol, informed consent document, HIPAA authorization form and any other study manuals. Promptly reviews signs-off, and files all essential documents.
- Informed Consent: Ensures that the most current version of the IRB approved protocol consent document and HIPAA authorization document is used when consenting a patient. Collaborates with the principal investigator to ensure initial and ongoing consent process is performed and documented. Assesses patient’s understanding of the information provided during the informed consent process. Ensures timely reconsent is obtained as necessary.
- Participant Recruitment & Retention: Identify, screen and enroll participants to clinical trials per established goals. Collaborates with the treating investigator to ascertain study participant eligibility for a clinical trial, ensuring there is documentation to support participant eligibility. Adheres to protocol and coordinates patient care systematically and within the parameters of the research study. Works with individual patients to address barriers to recruitment and retention. Develops relationships and maintains rapport with referring providers, clinical staff, and ancillary departments to facilitate compliance with the research study.
- Management of Clinical Trial Participants: Educates the patient and family regarding clinical trial participation, clinical condition, and/or disease process. Coordinates, schedules, and ensures timely completion of protocol-required events or other requirements. Evaluates patient’s adherence to and documentation of self-administered study agents and the return of such agent. Assesses adverse events and ensures evidence-based symptom management as permitted by the protocol. Collaborates with treating investigator to determine if dose modification is necessary and ensures the patient receives appropriate follow-up.
- Documentation and Document Management: Documents all participant encounters in the medical record and/or research record. Collects all supporting data including outside medical records and lab reports. Assesses documentation for discrepancies and ensures that inaccurate or discrepant documentation is addressed in the medical record or other source documents. Maintains the privacy and confidentiality of research participant’s source documents. Maintains essential documents per Good Clinical Practice. Utilizes departmental forms to document all required datapoints.
- Data Management: Adheres to study requirements for reporting research data. Ensures that relevant data from source documents are abstracted and reported in an accurate and timely manner and that all data reported can be verified within the source documents. Resolves queries promptly. Assists with the reporting of Serious Adverse Events (SAE) in accordance with the research protocol and reports follow-up safety data upon resolution of the SAE.
