Clinical Research Coordinator

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe.

Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world‑class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Be You.

Our team is looking for a proactive, self‑motivated team member who is comfortable working both independently and, in a team setting, and interfacing with Principal Investigators.

• Essential skills and qualities include:
• Highly organized
• Excellent attention to detail and communication skills
• Ability to successfully balance multiple competing priorities
• Comfortable in an Operating Room setting
• Comfortable collecting, processing, and transporting biological specimens
• Has a valid driver's license and reliable means of transportation

Preferred qualifications:

ACRP or SOCRA certification preferred.

This individual will support multiple research studies in the Reproductive Endocrinology and Infertility (REI) division of OBGYN, conducted by multiple investigators. Duties will include screening for research studies, obtaining written consent, conducting study visits, maintaining participant level documentation, and collecting, processing, and transporting research specimens. This position may also assist the Assistant Research Practice Manager with regulatory tasks. This position will work alongside and interact with multiple team members including: research staff, clinic staff and providers, surgeons, OR staff, hospital staff.

This position is 100% on site.

Education/Training:
Completion of an Associate’s Degree

Experience:

Work requires a minimum of two years relevant research experience. A bachelor’s degree may substitute for 2 years required experience.

Be Bold.

• Knowledgeable in regulatory and institutional policies and processes;
• Applies appropriately in study documentation, protocol submissions, and SOPs.
• May train others in these policies and processes.
• Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants.
• Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding. May train others. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.
• Addresses and corrects findings.
• Maintain all participant level documentation for studies that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR.
• Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention.
• Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues.
• Screens participants for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
• Provides oversight and training in screening activities to multiple study teams. Develops or helps develop SOPs.
• Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
• Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
• Conducts activities for study visits in compliance with the protocol.
• Participates in study team meetings.

• Identif…