FlexStaff is hiring a Clinical Research Coordinator, RN for our client, a cutting-edge cancer treatment center. In order to qualify, you must possess an active NY State RN license . As a Clinical Research Coordinator (CRC, RN), you will provide essential support to senior research staff, contributing to the daily operations of early-phase oncology clinical trials. You will ensure the accurate and timely conduct of research, strictly adhering to study protocols, regulatory guidelines, and patient safety standards.
Key responsibilities include :
- Direct patient interaction, meticulous data collection, and maintaining rigorous compliance with Good Clinical Practice (GCP).
- Managing a portfolio of multiple protocols, you will plan and coordinate patient participation, overseeing all aspects of the trial process.
- You will be responsible for the timely implementation and completion of all protocol-specific requirements, serving as a vital information conduit to the entire research team.
- Maintain regular, proactive communication with study sponsors, CROs, and internal staff regarding study status, questions, and concerns.
- Collaborate with the Principal Investigator (PI) on the timely completion and submission of Serious Adverse Event (SAE) reports.
- Work closely with the data coordinator team for Case Report Form (CRF) completion and query resolution.
Study Oversight & Compliance :
Oversee the day-to-day conduct of assigned studies, ensuring strict adherence to protocols, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) to maintain overall study integrity.Proactively identify and address protocol and SOP deviations, collaborating with leadership and staff to implement corrective and preventive actions. Document all deviations thoroughly.Develop and review study-related forms to assure protocol compliance.Patient Management & Support :
Facilitate the patient journey from screening and eligibility determination through the informed consent process.Provide comprehensive patient education regarding trial participation, investigational treatments (e.g., chemotherapy, biotherapy), and potential side effects.Perform telephone triage assessments for patients on trial as needed.Documentation & Training :
Lead the implementation of new protocols and amendments, providing comprehensive training to staff involved in patient care and study execution to ensure universal protocol adherence.Meticulously manage all study documentation, including source documents and trial master files, following established SOPs and standardized filing procedures.Administrative & Closeout :
Maintain an accurate and up-to-date contact list for all study personnel and stakeholders.Support study closeout activities in collaboration with the data coordinator team.Education and Experience :
Bachelor’s degree in Nursing highly preferred but associate's degree will be considered.Experience working in an oncology setting.RN license in state practicing.2 years of clinical research experience.Strong communication skills, both written and verbal.Basic understanding of oncology clinical trials, particularly Phase 1 studies.Strong attention to detail and accuracy in data collection and documentation.Ability to interact professionally with patients, study staff, and external stakeholders.Working knowledge of GCP and regulatory requirements.Proficient in Microsoft Office Suite and clinical trial management software.