Clinical Research Coordinator

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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.

This full-time onsite Clinical Research Professional (CRP) will participate in research conducted by the Division of Gastroenterology in the Department of Medicine under the supervision of the Principal Investigators (PIs) of the Gastroenterology Research Program. This CRP will perform a variety of research and duties including collaborating with physicians and nurses/clinic staff to obtain the samples, processing and management of samples in compliance with sponsor, regulatory, and institutional guidelines, repository-based work, consenting, enrollment, conducting subject visits, study and site documentation, data entry etc to support the conduct of clinical research.

Other tasks may include EMR review, participant screening, samples shipping, IP management, query resolution and participant payment processing. The CRP will be integrated into a larger clinical research team and is expected to collaborate on studies that will further the research mission of the Gastroenterology program. The Principal Investigators will provide supervision, regulatory oversight, mentorship, and guidance in the conduct of research.

• Completion of an Associate's degree

• Work requires a minimum of two years of relevant research experience. Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience.

Clinical Research-trials execution

• Necessary licenses, registrations, certifications, equipment used, and general information (ex: on-call, standby, inclement weather)

This position is (insert options below).

• Onsite. The work is performed on-site or at a designated assignment location.

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI). May train or oversee others. 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. May train others. 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. May train or oversee others. Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention. May train or oversee others. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems.

Escalates issues. May train or oversee others. Screens participants for complex studies (e.g., procedural and interventional studies). May train or oversee others. Develops or helps develop SOPs. May train or oversee others. Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures. May train or oversee others. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).

May train or oversee others. Conducts activities for study visits in compliance with the protocol. May train staff. Contributes to the…