CRC Specialist

START Center for Cancer Research • Bridgewater, NJ

2d

About The Position

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval. The START Center for Cancer Research is seeking a CRC Specialist to be responsible for leading the operational startup of new START USA sites by providing hands-on coordination and training in Phase I oncology trials. This role will temporarily fill the CRC role at launch sites, guide and mentor new CRC hires, and ensure the seamless execution of study start-up activities and early operations. In addition, this role will support existing START sites by covering CRC responsibilities during vacancies, ensuring no disruption in patient care or study conduct.

Requirements

• High School Diploma or GED.
• 5+ years of clinical research experience, with deep expertise in Phase I oncology trials.
• Proven record of successfully coordinating multiple complex protocols and mentoring other research staff.
• Exceptional communication, leadership, and training abilities.
• Demonstrated success in implementing quality improvement initiatives or standardization efforts.
• Strong command of clinical trial documentation, patient-facing procedures, and regulatory frameworks.
• Ability to travel up to 50% to various START USA locations as needed.
• Experience using clinical trial management systems (CTMS), EMRs, and sponsor IRT platforms.

Nice To Haves

• Bachelor’s degree.
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP).
• More than 5 years of experience in a lead CRC or trainer role within an oncology research setting.
• Formal training in adult learning principles or prior experience developing training materials.

Responsibilities

• Act as the interim CRC at new START sites during launch phase, managing study start-up, patient enrollment, and clinical coordination duties.
• Train and mentor the first on-site CRC at each new location, ensuring comprehensive onboarding to START SOPs, GCP compliance, and study-specific procedures.
• Serve as a trusted expert and role model for new and tenured CRCs across START USA.
• Travel to START sites as needed (approximately 50%) to support launch operations or in-person support for struggling sites.
• Support existing sites by covering CRC responsibilities during periods of leave, turnover, or unexpected staffing gaps.
• Collaborate with Study Operations leadership, Quality Assurance, and HR on continuous improvement of training programs and SOP implementation.
• Ensure protocol compliance, timely documentation, and coordination of patient-related activities for assigned studies, whether in-person or remote.
• Communicate effectively with site staff, investigators, sponsors, CROs, and patients to maintain study continuity and data integrity.
• Identify process inefficiencies or gaps and contribute to site-level or organizational CAPAs and workflow redesign initiatives.
• Participate in study start-up meetings, monitor protocol amendments, and ensure staff are trained on changes.
• Support implementation of best practices in patient consenting, AE/SAE documentation, and data collection across sites.
• Maintain expert-level understanding of current and evolving GCP, FDA, and institutional regulatory requirements.

Benefits

• Comprehensive health coverage: Medical, dental, and vision insurance provided
• Robust retirement planning: 401(k) plan available with employer matching
• Financial security: Life and disability insurance for added protection
• Flexible financial options: Health savings and flexible spending accounts offered
• Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 1-10 employees