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.

Grant/sponsor funded [50% or more external]

Operations:
Knowledgeable in regulatory and institutional policies and processes;  applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. 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. Prepares necessary documents, equipment, supplies, etc. 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. 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. 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. Learns and uses new technology when required.

Science:
Assists with simple literature searches. Under guidance, develops sections of protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs. 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. Ensures that studies are conducted in compliance with institutional requirements and other policies. 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 offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary  to get work done efficiently. Demonstrates resilience and is adaptive to change. 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 research in human lung transplantation and advanced lung diseases. Funding for these projects includes the National Institutes of Health (NIH), the Cystic Fibrosis Foundation, Duke University, and industry. Flexibility is expected for working hours due to the nature and timing of lung transplantation surgery as well as participants' clinic appointments.

Special skills:
Basic specimen processing and management skills e.g. centrifuging, pipetting, storage and tracking are preferred. Good communication skills are essential across a broad range of professional and medical disciplines in order to effectively coordinate specimen collection and successful completion of study aims.