Position: Clinical Research Coordinator (Oncology)

We are seeking a dedicated and experienced Oncology Clinical Research Coordinator (CRC) to join our team. This role is responsible for supporting clinical research activities, ensuring smooth trial operations, and maintaining compliance with regulatory requirements, Good Clinical Practice (GCP), and study protocols. The CRC will work closely with investigators, patients, and clinical staff to facilitate the successful execution of oncology studies.

Job Details:

• Full-time, On-site
• Monday to Friday (8-hour shifts)
• Permanent Position
• Professional references may be required

Key Responsibilities:

• Study Coordination: Manage daily operations of oncology clinical trials, including patient recruitment, informed consent, and scheduling study-related visits while ensuring adherence to protocols and regulations.
• Patient Interaction: Serve as the primary contact for study participants, providing guidance, addressing concerns, and monitoring patient safety while reporting adverse events as required.
• Data Management: Accurately collect, record, and maintain study data, ensuring proper documentation of case report forms (CRFs), source materials, and regulatory compliance.
• Regulatory Compliance: Ensure adherence to local, state, and federal regulations, including submission of study documents to Institutional Review Boards (IRBs) and regulatory bodies. Assist with audit and inspection preparations.
• Collaboration: Work closely with the Principal Investigator (PI), study sponsors, clinical research associates (CRAs), and other stakeholders to ensure timely data reporting and patient safety monitoring.
• Monitoring & Reporting: Track patient progress, maintain adherence to trial schedules, and provide regular updates on recruitment, patient status, and potential protocol deviations.
• Patient Education: Educate patients and their families about the clinical trial process, ensuring they have the necessary materials and information to make informed participation decisions.
• Study Documentation: Maintain thorough, organized, and up-to-date records of all study-related activities for audit readiness.

Qualifications:

• Education: Bachelor’s degree in Life Sciences, Nursing, or a related field (Certification in Clinical Research CCRP or CCRC preferred).
• Experience: Minimum 2 years of clinical research experience, with mandatory oncology experience. Strong knowledge of GCP, regulatory requirements, and oncology-specific protocols preferred.
• Skills:
  • Strong understanding of oncology clinical trials and treatment regimens
  • Proficient in data management and documentation
  • Excellent written and verbal communication skills
  • Strong organizational and multitasking abilities
  • Attention to detail and ability to work independently and collaboratively

Familiarity with clinical trial software and data management systems.