CLINICAL RESEARCH SPECIALIST, SR

Duke University-posted 2 months ago

$20 - $31/Yr

Full-time • Entry Level

Durham, NC

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Duke University School of Medicine is the youngest of the nation's top medical schools, established in 1930 and ranked sixth among medical schools in the nation. The School prides itself on being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced. The goal is to accelerate the translation of fundamental scientific discoveries to improve human health locally and globally. The School comprises more than 2,600 faculty physicians and researchers, nearly 2,000 students, and over 6,200 staff, forming part of Duke Health, a world-class academic medical center. The Health System includes Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, and various other health services.

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.
Prepares for study monitoring and audit visits under supervision.
Maintains participant-level documentation for non-complex studies outside of the EHR.
Follows SOPs and strategies to manage and retain research subjects.
Recruits research participants according to study protocol.
Screens participants in person or over the phone for non-complex studies.
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 non-complex visits and scripted testing or interviews.
Participates in study team meetings.
Recognizes known potential adverse events and reports to study team.
Conducts and documents consent for participants in non-complex studies.
Develops and submits documentation and information for IRB review under supervision.
Enters and collects basic data for research studies.
Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies.
Runs summaries and reports on existing data.
Follows required processes, policies, and systems to ensure data security and provenance.
Assists in preparing tables, data visualizations, and lay summaries to communicate study results.
Assists in updating reports on study progress for the PI and other study team members.
Assists with simple literature searches.
Develops elements of research protocols for simple studies under guidance.
Attends or schedules site visits as directed.
Records participant accrual information and consent documentation in clinical research management system.
Ensures studies are conducted in compliance with institutional requirements and other policies.
Assists in preparing studies for closeout as directed.
Maintains Duke and project specific training requirements.
Keeps current with research updates by attending key external departmental meetings.
Demonstrates resilience and is adaptive to change.
Communicates with other study personnel as required for study implementation.

Completion of an Associate's degree.
Minimum of two years of relevant research experience, or a Bachelor's degree may substitute for 2 years required experience.

Comprehensive and competitive medical and dental care programs.
Generous retirement benefits.
Wide array of family-friendly and cultural programs.

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