Duke University

Clinical Research Coordinator, Senior - Duke Cancer Institute

Duke University$69K — $110K *
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Associate's degree or Bachelor's degree with relevant research experience
  • Minimum six years of research experience, with Bachelor's degree substituting for two years
  • Experience in oncology, hematology, or cellular therapy research is preferred
  • Clinical trials coordination experience and management skills
  • Familiarity with multi-protocol complex research environments
  • BLS certification required
  • Compliance with SOPs and regulatory requirements essential

Responsibilities

  • Lead and coordinate operations for multiple complex oncology clinical trials
  • Oversee management of study documentation and regulatory compliance
  • Collaborate with Principal Investigators to develop key study documents
  • Manage financial tracking of trials and assist in budgeting
  • Act as liaison between sponsors and study staff for effective communication
  • Support data integrity using EDC systems and resolve data issues
  • Supervise research staff, enhancing performance and compliance
  • Foster a collaborative team culture focused on innovation and accountability

Benefits

  • Comprehensive medical and dental care programs
  • Generous retirement benefits
  • Family-friendly cultural programs
  • Opportunities for professional development and training
  • Access to various institutional resources and support services
Full Job Description
The Oncology Clinical Research Unit (CRU) within the Duke Cancer Institute is seeking a **Clinical Research Coordinator Sr.** to support the Leukemia/MPN Clinical Research Team (CRT) within the Hematologic Malignancies & Cellular Therapy (HMCT) Clinical Research Program. In this role, you will supervise a team of study coordinators and data managers/coordinators as part of your leadership of the day-to-day operations of a clinical research team conducting multiple, complex oncology clinical trials, including studies involving Investigational Products (IP). You will partner closely with Principal Investigators (PIs) and multidisciplinary teams to recruit, enroll, and support study participants while ensuring studies are conducted efficiently, ethically, and in compliance with institutional and regulatory requirements. This is an opportunity to take ownership of complex oncology trials, contribute to innovative research, and directly impact patient care and scientific advancement. **Minimum Requirements:** - Associate's degree - Minimum of six years of research experience - A Bachelor's degree may substitute for two years of required experience **Preferred Qualifications:** - Oncology, hematology, or cellular therapy research experience - Clinical trials coordination experience - Experience in complex, multi-protocol research environments - Management experience **Other Requirements:** - Basic Life Support (BLS) certification from the American Heart Association or a Duke-approved equivalent is required - Must maintain required certifications, training, and compliance with SOPs, regulations, and protocol requirements **Work Location:** - Onsite. The work is performed on-site within the Oncology Clinical Research Unit. **Position Responsibilities:** - **Lead study operations and coordination** for multiple complex oncology clinical trials, including participant recruitment, screening, enrollment, and retention strategies; evaluate processes and implement solutions to improve study performance - **Oversee study and site management activities**, including regulatory compliance, maintenance of study documentation (regulatory binders, enrollment logs, Delegation of Authority logs), adverse event reporting, and participant registration in systems of record - **Collaborate with Principal Investigators and study teams** to implement new studies, develop key documents such as Conflict of Interest (COI), Data Safety Monitoring Plans (DSMPs), and Research Data Security Plans (RDSPs), and troubleshoot study-related challenges - **Manage financial and operational aspects of trials**, including tracking study milestones, documenting study payments and participant care expenses, supporting budget development, and assisting with study closeout activities - **Serve as the primary liaison** between sponsors, PIs, and study personnel; communicate effectively and professionally while ensuring timely responses to inquiries and study needs - **Support data integrity and management**, including use of Electronic Data Capture (EDC) systems, resolving sponsor queries, identifying data issues, and ensuring completeness, accuracy, and security of research data - **Lead and supervise research staff**, including assigning work, managing performance, supporting professional development, conducting training, and ensuring compliance with protocols, SOPs, and regulatory requirements - **Foster a collaborative and high-performing team culture** by promoting open communication, mentoring staff, setting measurable goals, and encouraging innovation and accountability - **Ensure ethical conduct of clinical research**, educating staff and participants on the distinction between clinical care and research, and reinforcing adherence to professional guidelines, regulatory standards, and institutional policies - Perform other related duties as assigned Job Level: 53 **Anticipated Pay Range:** Duke University provides an annual base salary range for this position as USD $69,362.00 to USD $110,658.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer. Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

About Duke University

Duke University is a private research university in Durham, North Carolina. Founded by Methodists and Quakers in the present-day town of Trinity in 1838, the school moved to Durham in 1892. Duke's campus spans over 8,600 acres on three contiguous campuses in Durham as well as a marine lab in Beaufort. Duke University is consistently ranked among the top 20 universities in the United States and is a member of the prestigious Ivy League. Duke is also known for its highly ranked medical, law, and business schools. Duke University has a diverse student body, with students from all 50 states and over 100 countries. Duke University was founded in 1838 and is located in Durham, North Carolina.
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