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.

Operations:
Assists 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). Under supervision, prepares for study monitoring and audit visits. Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) 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 (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Follows SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study level documentation. Schedules participants for research visits (excluding those requiring EHR access). Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol. Conducts and documents non-complex visits and scripted testing or interviews.  May manage participant payment. Participates in study team meetings.

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 or minimal risk studies as defined by the IRB. These studies may include protocols with blood draws, repositories, survey studies, simple observational studies, and studies that do not involve investigational products or devices. Not permitted to tee up orders for second signature in Maestro Care. Assists with the development of consent plans and documents for participants. Under supervision, for non-complex studies (e.g., survey studies and registries), 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 non-complex studies. 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. Knowledgable about requirements for depositing data and following repository and meta-data specifications for data sharing. With guidance, locates and follows repository-specific requirements to submit study data for sharing. Understands and is able to identify when various data standards should be used in creating eCRFs and EDCs and integrates as according to best practices (E.g. IDC 10, CDISC, MedDRA, and WHODrug). Awareness of common data elements for research and understand how they would be applicable to their protocol(s). 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 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 and may conduct some testing and documentation for Part 11 projects.

Science:
May assist with simple literature searches under supervision from PI or CRC. 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).

Study and Site Management:
As directed, attends or schedules site visits. Records participant accrual information and consent documentation for non-complex studies in clinical research management system. Records 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. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).

Leadership:
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.


Description of Portfolio Responsibilities: (Effort .%):







Description of Clinical Responsibilities:

Clinical responsibilities:
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Type of Research:
This position will support multiple studies in the Pulmonary Transplant unit, including observational and registry studies.

Special skills:
This position will do some data management for internal reporting purposes, so data management experience is preferred.