CLINICAL RESEARCH SPECIALIST, SR

Clinical Research Specialist, Sr

Work Arrangement: On-Site

Location: Durham, NC, US, 27710

Personnel Area: MEDICAL CENTER

Be You. Operations: Knowledgeable in regulatory and institutional policies and processes. Applies knowledge to assist with study documentation, protocol submissions, and standard operating procedures (SOPs). Assists with study level documentation and approvals for international studies. Under supervision, assists with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring and audit visits. Maintains participant-level documentation for minimal risk (e.g., questionnaire, data registry, scripted) studies. Follows SOPs and strategies to manage and retain research participants. Recruits research participants according to study protocol. Screens participants in person or over the phone for minimal risk 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. Schedules participants for research visits. Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol. Conducts and documents minimal risk study 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 minimal risk studies, as defined by the IRB. These studies may include protocols with blood draws, repositories, survey studies, simple observational studies, and studies that do not involve investigational products or devices. Not permitted to tee up orders for second signature in Maestro Care. Assists with the development of consent plans and documents for participants. Under supervision, 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. Independently corrects and documents incomplete, inaccurate or missing data for minimal risk 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. Follows requirements for depositing data into an appropriate repository and meta-data specifications for data sharing. With guidance, locates and follows repository-specific requirements to submit study data for sharing. Learns and uses new technology when required. Assists with merging multiple datasets, recoding variables, and resetting scoring scales under supervision. Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants. Assists in updating and may develop 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. 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 contribution to scientific publications or presentations.

Study and Site Management: As directed, attends or schedules site visits. Records participant accrual information and consent documentation for minimal risk studies in clinical research management system. For studies with simple supplies or equipment, ensures 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.). Communicates with other study personnel as required for study implementation and routine problem resolution.

Type of Research: This position will assist with ophthalmology trials

Choose Duke. Anticipated Pay Range: USD $20.76 to USD $31.44

Equal Opportunity Employer: Duke is an 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 (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.