Clinical Research Specialist Sr

This Position is Grant Funded

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.

 

Type of Research:
The Clinical Research Specialist, Sr. (CRS Sr.) will join a growing research team working on studies led by investigators in the Duke Center for Aging. Studies will focus on neurocognition and health disparities, with a focus in the Hispanic/Latino population. Proficiency in oral and written Spanish and English is required. This will be an on-site position, and may require travel to off-site locations. Candidates must have a valid NC driver's license or be eligible to obtain a NC driver's license before the start of the position, and must have a reliable, insured vehicle and be willing to drive it for research-related tasks.

Special skills:
Preferred Skills:     The ideal candidate will:  •   Possess excellent verbal and written communication skills in both Spanish and English •    Exhibit familiarity or ease communicating and relating to older adults •   Demonstrate the ability to plan, organize, and prioritize workload to meet deadlines • Be willing to be flexible in order to accomplish the shared goals of projects •  Demonstrate willingness to acquire new skills

Operations:
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. 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. 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 polic