Clinical Research Specialist, Sr.

Duke Careers•Durham, NC

1d•$23 - $35•Onsite

About The Position

This position will support the entire lung transplant portfolio, which includes primarily repositories/specimen collection and treatment trials. Duke University School of Medicine, established in 1930, is a highly-ranked institution known for its interdisciplinary collaboration and commitment to translating scientific discoveries into improved human health. Duke Health comprises the School of Medicine, School of Nursing, and Duke University Health System, a comprehensive academic medical center.

Requirements

Associate’s degree
One year of relevant experience required.
Completion of the DOCR North Carolina approved Clinical Research Pre Apprenticeship program may substitute for one year of required experience.

Nice To Haves

Specimen processing experience is a plus

Responsibilities

Assist with study documentation, protocol submissions, and standard operating procedures (SOPs).
Assist with managing investigational products (IP) including arrival, storage, and handling.
Prepare for study monitoring and audit visits.
Maintain participant-level documentation for minimal risk studies.
Follow SOPs and strategies to manage and retain research participants.
Recruit research participants according to study protocol.
Screen participants in person or over the phone for minimal risk studies or collect information from the EHR to assist study team in determining eligibility.
Independently employ simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
Assist with establishing and maintaining study level documentation.
Prepare documents, equipment, supplies, etc. in compliance with the protocol.
Assist with the conduct and documentation of minimal risk study visits and scripted testing or interviews.
Participate in study team meetings.
Recognize potential adverse events and report to study team.
Conduct and document consent for participants in minimal risk studies.
Assist with the development of consent plans and documents for participants.
Develop and submit documentation and information for IRB review.
Assist with the compilation of documents needed for regulatory and safety reporting to sponsors and other agencies.
Enter and collect basic data for research studies.
Score scripted or validated tests and measures.
Correct and document incomplete, inaccurate or missing data for minimal risk studies.
Run summaries and reports on existing data.
Ensure data security and provenance.
Recognize and report security of physical and electronic data vulnerabilities.
Deposit data into an appropriate repository and follow meta-data specifications for data sharing.
Locate and follow repository-specific requirements to submit study data for sharing.
Follow requirements for use of data standards for developing research databases.
Assist with merging multiple datasets, recoding variables, and resetting scoring scales.
Assist in preparing tables, data visualizations, and lay summaries to communicate study results to participants.
Update and develop reports on study progress for the PI and other study team members and collaborators.
Execute testing process after the completion of a build, or following any project changes or system upgrades.
Conduct testing and documentation for Part 11 projects.
Assist with simple literature searches.
Develop elements of research protocols for simple studies.
Provide contribution to scientific publications or presentations.
Attend or schedule site visits.
Record participant accrual information and consent documentation for minimal risk studies in clinical research management system.
Record basic protocol information in clinical research management system.
Ensure ample supplies and that equipment is in good working order for studies with simple supplies or equipment.
Follow protocol-specific systems and process flows.
Assist in preparing studies for closeout.
Work with the manager to understand areas of opportunity and develop a training plan.
Take training courses and apply the knowledge and skills.
Train others in the skills learned.
Keep current with research updates by attending key external departmental meetings.
Communicate with other study personnel as required for study implementation and routine problem resolution.