Clinical Research Specialist, Sr.

About the role

The School of Medicine at Duke University is seeking a Research Assistant to support clinical research operations. This position will assist with managing investigational products, preparing for study monitoring and audits, recruiting research participants, and conducting minimal risk study visits.

Responsibilities

• Assists with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering).
• Prepares for study monitoring and audit visits.
• Applies knowledge to assist with study documentation, protocol submissions, and standard operating procedures (SOPs).
• Maintains participant level documentation for minimal risk studies.
• Screens participants in person or over the phone for minimal risk studies (e.g., questionnaire, data registry, scripted).
• Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
• Schedules participants for research visits and 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.
• Follows standard operating procedures (SOPs) and participates in study team meetings.
• Recognizes and reports known potential adverse events (AEs) and conducts and documents consent for participants in minimal risk studies.
• Develops and submits documentation and information for IRB review.
• Enters and collects basic data for research studies, scores scripted or validated tests and measures, independently corrects and documents incomplete, inaccurate, or missing data for minimal risk studies, and follows SOPs for quality assurance (QA).
• Runs summaries and reports on existing data, assists with merging multiple datasets, recoding variables, and resetting scoring scales under supervision.
• Follows required processes, policies, and systems to ensure data security and provenance, recognizes and reports security of physical and electronic data vulnerabilities, and follows requirements for depositing data into an appropriate repository, meta data specifications for data sharing, and the use of data standards for developing research databases.
• Learns and uses new technology when required.
• 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 Principal Investigator (PI) and other study team members and collaborators.
• 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.
• Assists with simple literature searches.
• Develops elements of research protocols for simple studies (e.g., registries, survey studies).

Requirements

• Education: An Associate's degree.
• Experience: One year of relevant experience. Completion of the DOCR North Carolina state approved Clinical Research Pre Apprenticeship program may substitute for one year of required experience.

Qualifications

• Knowledge of regulatory and institutional policies and processes.
• Ability to easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

Skills

• Basic computer skills.

Benefits

Details about benefits are available at: https://hr.duke.edu/benefits/

Pay

Anticipated Pay Range: USD $23.00 to USD $34.50 per year.

Schedule

Details about the schedule are available upon request.