Clinical Research Associate - Oncology

Employment Type:

Full time

Shift: Day Shift

Description:

The Clinical Research Associate (Oncology) is responsible for coordinating and managing oncology clinical research studies to ensure the safe, ethical, and compliant conduct of clinical trials. This role facilitates study start-up, patient screening and enrollment, protocol implementation, data collection, regulatory documentation, and ongoing study oversight in accordance with federal regulations, Good Clinical Practice (GCP) guidelines, sponsor requirements, and Institutional Review Board (IRB) policies.

The Clinical Research Associate serves as a key liaison among research participants, investigators, sponsors, and multidisciplinary healthcare teams to support the successful execution of oncology research protocols. Through effective study coordination, data integrity management, and participant advocacy, this position contributes to the advancement of cancer care, clinical innovation, and organizational research objectives.

The Clinical Research Associate (Oncology) supports the successful execution of oncology clinical research studies by coordinating study activities, ensuring regulatory compliance, and maintaining the integrity of research data. This role works collaboratively with investigators, research participants, sponsors, and multidisciplinary healthcare teams to facilitate patient recruitment, protocol implementation, data collection, and study oversight. The Clinical Research Associate helps ensure that clinical trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, federal regulations, Institutional Review Board (IRB) requirements, and organizational policies while promoting participant safety, research quality, and ethical standards.

Through effective study coordination and operational support, this position contributes to the advancement of cancer research, innovative treatment options, and improved patient outcomes.

Education:

Bachelor's degree in biological sciences, health sciences, or medical field. CITI research ethics training required (on-site training provided).

Experience:

Two (2) to four (4) years of experience in clinical research required (oncology preferred). Experience using Electronic Data Capture (EDC) systems preferred. Effective communication skills, knowledge of research regulatory and data management requirements, ability to work independently, and strong time management skills.

• Coordinate and manage assigned oncology clinical trials from study start-up through closeout, ensuring compliance with protocol requirements, regulatory standards, and organizational policies.
• Screen, recruit, and refer eligible research participants to care providers in accordance with study protocols and informed consent requirements.
• Coordinate participant visits, assessments, treatments, laboratory testing, and follow-up activities required by research protocols.
• Serve as a primary liaison among investigators, research participants, sponsors, contract research organizations (CROs), and internal clinical departments.
• Collect, review, verify, and enter clinical research data into electronic data capture systems, ensuring accuracy, completeness, and timeliness.
• Maintain study documentation, regulatory binders, investigator site files, and essential study records in accordance with Good Clinical Practice (GCP) guidelines.
• Prepare and submit required regulatory documents, protocol amendments, continuing reviews, adverse event reports, and study-related correspondence to the Institutional Review Board (IRB).
• Monitor participant compliance with study protocols and identify, document, and report protocol deviations as required.
• Track and resolve…