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 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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

 

Occupational Summary

 

Participate in or lead day-to-day operations of clinical research studies conducted by principal investigator in the Emergency Medicine Division, within The Department of Surgery; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data.

 

        1.  This position will be in-person and involves weekdays and weekends.

 

        2.  There will be team coverage for the Emergency Medicine (EM) department, which operates from 8 am to 8 pm.

 

        3.  The schedule may vary on a weekly basis due to the dynamic and fast-paced nature of the EM environment. Assignments and tasks may switch             unpredictably, requiring applicants to be adaptable to this environment.

 

Work Performed

 

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 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.

 

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