Job Description

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.

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