CLINICAL RESEARCH SPECIALIST, SR

Duke Careers•Durham, NC

5d•$21 - $31

About The Position

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations. Operations: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 non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. 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 non-complex 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 (excluding those requiring EHR access). Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment. 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 non-complex studies or 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, for non-complex studies (e.g., survey studies and registries), 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 non-complex 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. 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. 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 non-complex studies in clinical research management system. For studies with simple supplies or equipment, assists with ensuring 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:We are looking for someone to work with our CRCs to assist with study visit (perform ophthalmic testing required by the protocol). Special skills:Willingness to learn ophthalmology

Requirements

Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
Work requires an Associate 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.

Nice To Haves

Willingness to learn ophthalmology

Responsibilities

Assists with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering).
Prepares for study monitoring and audit visits.
Maintains participant-level documentation for non-complex studies outside of the EHR.
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 non-complex studies or may collect information from the EHR to assist study team in determining eligibility.
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 (excluding those requiring EHR access).
Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol.
Conducts and documents non-complex visits and scripted testing or interviews.
May manage participant payment.
Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team.
Conducts and documents consent for participants in non-complex studies or minimal risk studies as defined by the IRB.
Assists with the development of consent plans and documents for participants.
For non-complex studies, develops and submits documentation and information for IRB review.
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.
Follows SOPs for quality assurance.
Runs summaries and reports on existing data.
Follows required processes, policies, and systems to ensure data security and provenance.
Recognizes and reports security of physical and electronic data vulnerabilities.
Learns and uses new technology when required.
Assists with merging multiple datasets, recoding variables, and resetting scoring scales under supervision.
Assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants.
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.
Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies).
Provides some contribution to scientific publications or presentations.
As directed, attends or schedules site visits.
Records participant accrual information and consent documentation for non-complex studies in clinical research management system.
For studies with simple supplies or equipment, assists with ensuring 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).
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.
Assist with study visit (perform ophthalmic testing required by the protocol).

Benefits

Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family- friendly and cultural programs to eligible team members.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume