Clinical Research Coordinator

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest among the top U.S. medical schools, ranked sixth nationally. It fosters an inclusive community of learners, investigators, clinicians, and staff, emphasizing interdisciplinary collaboration to translate scientific discoveries into health improvements globally. The school comprises over 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff members. It is part of Duke Health, which includes Duke University School of Nursing, Duke University Hospital, and other affiliated facilities.

• Recognizes when agreements (MTAs, CDAs, DUAs, DTAs) are needed and alerts relevant parties.
• Prepares FDA regulatory submissions in collaboration with ORAQ, maintaining documentation and addressing review issues.
• May train others, applying knowledge of policies in study documentation and protocol submissions.
• Manages study documentation, including international studies, and develops resources for study management.
• Handles Investigational Product (IP) logistics and serves as liaison with sponsors and other parties.
• Follows protocol schemas for randomization and blinding/unblinding, and supports study monitoring and audits.
• Maintains participant documentation, employs strategies for retention and recruitment, and screens participants for complex studies.
• Develops or updates SOPs, manages research specimens, and conducts complex study visits.
• Leads multidisciplinary meetings and ensures study compliance and closeout.

• Identifies and reports adverse events, collaborates on AE attribution, and trains staff in consent procedures.
• Prepares IRB submissions, communicates with IRB staff, and handles regulatory reporting.

• Enters, collects, and ensures data quality, develops SOPs, and trains team members.
• Recognizes data vulnerabilities, maps data flow, and uses technology for productivity.

• Contributes to funding proposals, conducts literature reviews, develops research protocols, and contributes to scientific publications.

• Prepares for site visits, manages research activities via systems, and assesses study feasibility.
• Ensures study supplies and equipment are adequate, and prepares for study closeout.

• Seeks skill development, participates in committees, navigates research processes, and demonstrates organizational awareness and interpersonal skills.

The Clinical Research Coordinator (CRC) will manage complex Rheumatology studies, handling all daily activities and regulatory tasks in collaboration with the Division Lead.

Organizational, communication, technology skills, medical terminology knowledge, attention to detail, resourcefulness, independence, and problem-solving abilities. Prior Duke clinical trial experience is preferred.

Duke is an Affirmative Action/EOE employer. The salary range is USD $58,656 to $98,000 annually, influenced by experience, education, and market factors. Benefits include medical, dental, retirement, and family programs. Physical and mental abilities required for the role will be specified by the hiring department.

• Associate's degree completion.
• Minimum two years of relevant research experience;
  Bachelor's degree may substitute for experience.