Type of Research

The Clinical Research Specialist Sr. will join a growing research team working on long-term studies led by investigators in the Duke Center for Aging and the Department of Neurology. Ongoing studies are focused on Alzheimer’s Disease and related neurocognitive disorders.

This position will involve research operations, data collection and quality assurance activities, and assistance with study management. This position will involve working with collaborators at multiple sites and may require travel between clinics and offsite locations.

Preferred Skills:

The ideal candidate will:

· Possess excellent verbal and written communication skills

·Possess human subjects clinical research experience

·Exhibit familiarity or ease communicating and relating to older adults

·Demonstrate skill in attention to detail and organization

·Demonstrate flexibility and willingness to acquire new skills

·Showcase their proven ability to work both independently and within a team with excellence, dignity, and respect

Occupational Summary

Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research under the supervision of a Clinical Research Coordinator or similar Clinical Research Units (CRU)/Oversight Organization (OO) designee. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data and may train other Clinical Research Specialists (CRS) in these tasks.

Work Performed

1. Research Operations.

Screens participants in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the electronic health record (EHR) to assist the study team in determining eligibility. Recruit research participants according to study protocol and follow standard operating procedures (SOPs) and strategies to manage and retain research subjects. Schedules participants for research visits and prepares necessary documents, equipment, supplies, etc. Conducts and documents non-complex visits and scripted testing or interviews and may manage participant payment. Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Assists with establishing and maintaining study-level documentation. May assist 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) and prepares for study monitoring and audit visits. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Follows SOPs and participates in study team meetings.

2. Safety and Ethics

Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to the 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.

3. 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 and 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 the security of physical and electronic data vulnerabilities. Learns and uses new technology when required.

4. Scientific Concepts

with simple literature searches. Under guidance, develop sections of protocols for simple studies (e.g., registries, survey studies). Provides some contribution to scientific publications or presentations (no authorship).

5. Site and Study Management.

As directed, attends or schedules site visits and assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor). Associates patients with studies in CRMS. For studies with simple supplies or equipment, ensure that there are ample supplies and that equipment is in good working order. Follows protocol-specific systems and process flows.

6. Leadership and Professionalism

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.). Communicates with other study personnel as required for study implementation and routine problem resolution.