Cancer Care Research Coordinator
2 weeks ago
- Position Overview
- The Oncology Clinical Research Coordinator (CRC) plays a vital role in supporting the clinical Principal Investigator (PI) in the management of ongoing research initiatives. The CRC is tasked with the facilitation and organization of daily clinical trial operations related to Cancer Care Delivery Research (CCDR) and cancer control studies as directed by the Oncology Clinical Research department's Manager. This role may also extend to non-treatment and Quality of Life research as needed. The CRC is accountable for ensuring adherence to study protocols, relevant regulations (including FDA guidelines), Good Clinical Practice (GCP), and Institutional Review Board (IRB) standards. A background in healthcare and familiarity with the oncology research landscape is essential for this position. Responsibilities include, but are not limited to: reviewing medical records to identify eligible patients, assisting in the informed consent process, coordinating patient appointments to meet protocol specifications, recruiting and enrolling study participants, and managing data collection and entry. Additionally, the CRC may contribute to the evaluation of clinical trial protocols for site feasibility. This role requires the ability to work collaboratively within a team and independently under general supervision.
- Educational Background
- Bachelor's Degree - Preferred
- Professional Experience
- 2-3 Years of Experience in Oncology - Preferred
- 1 Year of Experience in Clinical Research - Preferred
- Certifications
- Certified Clinical Research Coordinator (CCRC) - Preferred
- Certification must be obtained within 2 years of employment
- Basic Life Support (BLS) Certification - Required
- Key Responsibilities
- Oversee study activities for assigned protocols to ensure compliance with study requirements and local, federal, state, and institutional regulations. Maintain comprehensive documentation related to study activities, including case report forms, source documents, pharmacy drug binders, and regulatory paperwork.
- Evaluate the eligibility of potential subjects through various methods, including medical record reviews and discussions with healthcare providers. Actively engage in patient recruitment by discussing potential candidates with investigators, approaching them in the office or via phone, asking pre-screening questions, explaining the trial to patients, and conducting the informed consent process.
- Coordinate and supervise participant visits and any necessary tests or imaging as per the protocol. Ensure that visits, tests, and imaging are scheduled within the appropriate timeframe and completed at each required interval. Monitor patient adherence to medication and maintain drug accountability for assigned protocols.
- Monitor subjects in accordance with protocol requirements, ensuring that any modifications to study treatment are overseen by the investigator and/or CRC under the investigator's supervision. Track patients throughout the trial for any adverse reactions and communicate findings to the investigator promptly.
- Document and report adverse events, ensuring that they are reviewed and followed up by the treating physician. Collaborate with the investigator to monitor patient care and treatment side effects while maintaining detailed documentation for reporting and source verification.
- Responsible for the collection, processing, preparation, and shipping of laboratory specimens.
- Gather participant data, enter it into appropriate databases, and address data queries promptly.
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