Clinical Research Specialist, Sr

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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.

Be You.

You will help support the entire lung transplant portfolio, which includes primarily repositories/specimen collection and treatment trials.

• • Work requires an Associate’s degree
  • One year of relevant experience required. Completion of the DOCR North Carolina approved Clinical Research Pre Apprenticeship program may substitute for one year of required experience

• Specimen processing experience is a plus

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

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

Be Bold.

Knowledgeable in regulatory and institutional policies and processes. Applies knowledge to assist with study documentation, protocol submissions, and standard operating procedures (SOPs). Assists with study level documentation and approvals for international studies. Under supervision, assists with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring and audit visits. Maintains participant-level documentation for minimal risk (e.g., questionnaire, data registry, scripted) studies.

Follows SOPs and strategies to manage and retain research participants. Recruits research participants according to study protocol. Screens participants in person or over the phone for minimal risk studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Follows SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.

Assists with establishing and maintaining study level documentation. Prepares documents, equipment, supplies, etc. in compliance with the protocol. Assists with the conduct and documentation of minimal risk study visits and scripted testing or interviews. Participates in study team meetings.

Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team. Conducts and documents consent for participants in minimal risk studies, as defined by the IRB. These studies may include protocols with blood draws, repositories, survey studies, simple observational studies, and studies that do not involve investigational products or devices. Not permitted to tee up orders for second signature in Maestro Care.

Assists with the development of consent plans and documents for participants. Under supervision, develops and submits documentation and information for IRB review. Assist with the compilation of documents needed for regulatory and safety reporting to sponsors and other agencies.

Enters and collects basic data for research studies. May score scripted or validated tests and measures. Independently corrects and documents incomplete, inaccurate or missing data for minimal risk studies. Follows SOPs for quality assurance. Runs summaries and reports on existing data. Follows required processes, policies, and systems to ensure data security and provenance. In addition, recognizes and reports security of physical and electronic data vulnerabilities.

Follows requirements for depositing data into an appropriate repository and meta-data…