SENIOR CLINICAL RESEARCH SPECIALIST

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:
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. 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. 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. Under supervision, may document some participant-level information 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. Under supervision, collects information from sources including 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 maintenance of study level documentation. Prepares documents, equipment, supplies, etc. in compliance with the protocol. Assists with the conduct and documentation of non-complex visits and scripted testing or interviews. 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). 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 basic data for research studies.  Scores tests and measures that do not require interpretation, according to the protocol. 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.

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).

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.

Leadership:
Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). Navigates processes and people involved in Duke clinical research, demonstrates 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.





Type of Research:
This position will help the CRCs in the EM acute care area with the enrolment of minimal-risk studies and student studies. It will be responsible for having binders and kits prepare in advance so CRC and screen our dashboard

 

Minimum Qualifications

Education

Work requires an Associate's degree.

Experience

One year of relevant experience. A Bachelor's degree may substitute for required experience.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.