Senior Clinical Research Specialists, Duke Cancer Center

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.

Senior Clinical Research Specialists

Oncology Clinical Research Unit [CRU]

Thoracic Clinical Research Program [THRC]

 

Position Description, 11/2023

Occupational Summary

Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research for the Duke Cancer Institute’s [DCI] Thoracic Clinical Research Program. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data.  The Oncology Clinical Research Unit [CRU] oversees the conduct of research. 

Work Preformed

Research Operations – 10% Effort

Screen participants, conduct and document consent for participants in minimal risk studies. Maintain subject level documentation.  Schedule participants for study visits.  Prepare necessary documents, equipment, supplies, and  interviews according to study protocol and Standard Operating Procedures [SOPs]. 

Follow procedures and documentation of study payment.  Assist with maintenance of study level documentation.  Define source document. 

Collect, prepare, process, ship, and maintain inventory of research specimens. 

Safety and Ethics – 10% of Effort

Recognize known potential adverse events, identified in the protocol or investigator brochure, and report to sudy team. Conduct and document consent for participants in non-complex studies. These are typically repositories, survey studies, simple observational studeien and non-patient studies that do not involove investigational products or devices.

Cannot consent for any studies that involoveinvestigational products or devices or required clinical research orders in Maestro Care (i.e., electronic health record). Assist with the development of consent plans and documents for participants.

Data – 60% of Effort

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 follow SOPs for quality assurance.

Run summaries and reports on exisiting data. Follw required processes, policies, and systems to ensure data secruity and provenance.

Recognize and report security of physical and electronic data vulnerabilities. Learn and use new technology when required.

Scientific Concepts –5% Effort

Assist with simple literature searches. Under guidance, develop sections of protocols for simple studies (e.g., registries, survey studies.) Provide some contribution to scientific publications or presentations (no authorship).

Site and Study Management – 10% of Effort

As directed, attend or schedule site visits and assist in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponosr).

Associate patients with studies in CRMS. For studies with simple supplies or equipment, ensure that there are ample supplies and that equipment is in good working order. Follow protocol-specific systems and process flows.

Leadereship and Professionalism – 5% of Effort

Work with the manager to understand areas of opportunity and develop a training plan. Take traninin gcourses and apply the knowledge andskills. May also train others in the skills learned.

Keep current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.).

Communicate with other study personnel as required for study implementation and routine problem resolution.

And other work as assigned. 

Basic Life Saving [BLS] certification from the American Heart Association or Duke approved equivalent course is a requiremen