SENIOR CLINICAL RESEARCH SPECIALIST

School of Medicine

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.

Operations:
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. 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. Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring and audit visits. Under supervision, may document some participant-level information for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Under supervision, collects information from sources including the EHR to assist study team in determining eligibility. Follows SOPs. Under supervision, employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with maintenance of study level documentation. Prepares documents, equipment, supplies, etc. in compliance with the protocol. Assists with the conduct and documentation of non-complex visits and scripted testing or interviews. Participates in study team meetings.

Ethics:
Under supervision may collect information about AEs, identified in the protocol or investigator brochure. Conducts and documents consent for participants in non-complex studies. These are typically repositories, survey studies, simple observational studies and non-patient studies that do not involve investigational products or devices. Cannot consent for any studies that involve investigational products or devices or require clinical research orders in Maestro Care (i.e., electronic health record). Assists with the development of consent plans and documents for participants. Under supervision, for non-complex studies (e.g., survey studies and registries), develops and submits documentation and information for IRB review. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Data:
Enters basic data for research studies.  Scores tests and measures that do not require interpretation, according to the protocol. Under supervision, corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance.

Science:
Assists with or contributes to the development of funding proposals. Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs.

Study and Site Management:
As directed, attends or schedules site visits. Records participant accrual information and consent documentation for non-complex studies in clinical research management system. Records basic protocol information in clinical research management system. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations. For studies with simple supplies or equipment, assists with ensuring that there are ample supplies and that equipment is in good working order. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).

Leadership:
Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge an