Clinical Research Specialist, Sr. - Psychiatry- Doraiswamy

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:
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. 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. Under supervision, 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:
Under supervision may collect information about AEs, identified in the protocol or investigator brochure. 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).

Data:
Enters and collects basic data for research studies. May score scripted or validated tests and measures. Under supervision, corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Follows required processes, policies, and systems to ensure data security and provenance. Learns and uses new technology when required. Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants.

Science:
Assists with simple literature searches. Contributes to the development of scientific publications or presentations.  Serves as an author on poster presentations or publications.

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, assists with ensuring 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.). Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Description of Portfolio Responsibilities: (Effort .%):
Phone screen interested participants and coordinate scheduling of appointments – 40%