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 2,600 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.

Occ Summary

Performs 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 (CRC) or similar Clinical Research Unit (CRU), Oversight Organization (OO) designee. Participates in day to day operations related to the collection, compilation, and documentation of clinical research data and may train Clinical Research Specialists (CRSs) in these tasks.

Work Performed

Research Operations Under supervision, assists with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering) and prepares for study monitoringand audit visits. Knowledgeable in regulatory and institutional policies and processes. Applies knowledge to assist with study documentation, protocol submissions, and standard operating procedures (SOPs). Maintains participant level documentation for minimal risk studies, as defined by Institutional Review Board (IRB). Recruits research participants according to study protocol and follows SOPs and strategies to manage and retain research participants. Screens participants in person or over the phone forminimal risk studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study level documentation; may perform for international studies. Schedules participants for research visits.Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol. Conducts and documents minimal risk study visits and scripted testing or interviews. May manage participant payment. Follows standard operating procedures SOPs and participates in study team meetings. Safety and Ethics Recognizes known potential adverse events (AEs), identified in the protocol or investigator brochure, and reports to study team. Conducts and documents consent for participants in minimal risk studies. These studies may include protocols with blood draws, repositories, survey studies, simple observational studies, and studies that do not involve investigational products or devices. This position does not have access in the EHR to tee up orders for second signature in Maestro Care. Assists with the development of consent plans and documents for participants and compiling documents needed for regulatory and safety reporting to sponsors and other agencies. Under supervision develops and submits documentation and information for IRB review. 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 minimal risk studies and follows SOPs for quality assurance (QA). Runs summaries and reports on existing data. Assists with merging multiple datasets, recoding variables, and resetting scoring scales under supervision. 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, meta data specifications for data sharing, and the use of data standards for developing research databases. (E.g. IDC 10, CDISC, MedDRA, and WHODrug). With guidance, locates and follows repository specific requirements to submit study data for sharing. Learns and uses new technology when required. Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants. Assists in updating and may develop reports on study progress for the Principal Investigator (PI) and other study team members and collaborators. Under supervision, executes testing process after the completion of a build, or following any project changes or system upgrades. May conduct some testing and documentation for Part 11 projects. Scientific Concepts Assists with simple literature searches. Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies). Provides some contribution to scientific publications or presentations. (no authorship) 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). Records participant accrual information and consent documentation for minimal risk studies, and basic protocol information in clinical research management system.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. 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).

Level Characteristics

Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

Minimum Qualifications

Education

Work requires an Associate's degree.

Experience

One year of relevant experience. Completion of the DOCR North Carolina state approved Clinical Research Pre Apprenticeship program may substitute for one year of required experience.

Degrees, Licensures, Certifications

One year of relevant experience. Completion of the DOCR North Carolina state approved Clinical Research Pre Apprenticeship program may substitute for one year of required experience.