CLINICAL RESEARCH SPECIALIST, SR

Duke Careers•Durham, NC

6d•$21 - $31

About The Position

Duke University School of Medicine, established in 1930, is a highly-ranked institution known for its inclusive community and interdisciplinary collaboration. It is a world-class academic medical center comprising the School of Medicine, School of Nursing, and Duke University Health System. The Health System includes 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 various affiliations. This role will assist with ophthalmology trials.

Requirements

Associate's degree
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.
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

Responsibilities

Assist with study documentation, protocol submissions, and standard operating procedures (SOPs).
Assist with study level documentation and approvals for international studies.
Under supervision, assist with managing investigational products (IP) including arrival, storage, and handling.
Under supervision, 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.
Schedule participants for research visits.
Prepare necessary documents, equipment, supplies, etc. in compliance with the protocol.
Conduct and document minimal risk study visits and scripted testing or interviews.
May manage participant payment.
Participate in study team meetings.
Recognize known 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.
Under supervision, develop and submit documentation and information for IRB review.
Enter and collect basic data for research studies.
May score scripted or validated tests and measures.
Independently correct and document incomplete, inaccurate or missing data for minimal risk studies.
Follow SOPs for quality assurance.
Run summaries and reports on existing data.
Follow required processes, policies, and systems to ensure data security and provenance.
Recognize and report security of physical and electronic data vulnerabilities.
Follow requirements for depositing data into an appropriate repository and meta-data specifications for data sharing.
With guidance, locate and follow repository-specific requirements to submit study data for sharing.
Learn and use new technology when required.
Assist with merging multiple datasets, recoding variables, and resetting scoring scales under supervision.
Under supervision, assist in preparing tables, data visualizations, and lay summaries to communicate study results to participants.
Assist in updating and may develop reports on study progress for the PI and other study team members and collaborators.
Under supervision, execute 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.
Assist with simple literature searches.
Under guidance, develop elements of research protocols for simple studies.
Provide some contribution to scientific publications or presentations.
As directed, attend or schedule site visits.
Record participant accrual information and consent documentation for minimal risk studies in clinical research management system.
For studies with simple supplies or equipment, ensure that there are ample supplies and that equipment is in good working order.
Follow protocol-specific systems and process flows.
As directed, 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.
May also 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.