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.

 

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. 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

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.

 

Assists with quality control and data cleaning as directed. Independently responds to queries created by a CRO or the data manager.

 

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. Documents and maintains documentation to facilitate data sharing during publication or study closeout.

 

For non complex protocols, identifies when various data standards should be used in creating eCRFs and EDCs and integrates as according to best practices.

 

Knowledgeable about the use of data standard policies. 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 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
 

Assists with simple literature searches. Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies).

 

Provides some c