CLINICAL RESEARCH SPECIALIST, SR
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research under the supervision of a Clinical Research Coordinator or similar Clinical Research Units(CRU)/Oversight Organization (OO) designee. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data and may train Clinical Research Specialists (CRS) in these tasks.
1. Research Operations. Screens participants in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the electronic health record (EHR) to assist study team in determining eligibility. Recruits research participants according to study protocol and follows standard operating procedures (SOPs) and strategies to manage and retain research subjects. Schedules participants for research visits and prepares necessary documents, equipment, supplies, etc. Conducts and documents non-complex visits and scripted testing or interviews and may manage participant payment. Maintains participant- level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Assists with establishing and maintaining study-level documentation. May assist with study level documentation and approvals for international studies. Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering) and prepares for study monitoring and audit visits. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Follows SOPs and participates in study team meetings.
2. Safety and Ethics. Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team. 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 devicesor require clinical research orders in Maestro Care (i.e., electronic health record). Assists with the development of consent plans and documents for participants.
3. Data. 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 non-complex studies and 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. Learns and uses new technology when required.
4. Scientific Concepts. Assists with simple literature searches. Under guidance, develops sections of protocols for simple studies (e.g., registries, survey studies). Provides some contribution to scientific publications or presentations (no authorship).
5. Site and Study Management. As directed, attends or schedules site visits and assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor). Associates patients with studies in CRMS. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. Follows protocol-specific systems and process flows.
6. Leadership and Professionalism. Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills. May also train others in the skills learned. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). Communicates with other study personnel as required for study implementation and routine problem resolution.
Knowledge, Skills and Abilities
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
Work requires an Associate's degree.
One year of relevant experience. A Bachelor's degree may substitute for required experience.
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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.