Clinical Research Specialist, SR.

Operations:

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. 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. Under supervision, 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. Participates in study team meetings.

Ethics:

Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to the 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 in updating reports on study progress for the PI and other study team members and collaborators.

Science:

Demonstrates a basic understanding of the elements of research study designs.

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. Records basic protocol information 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. Ensure that studies are conducted in compliance with institutional requirements and other policies. 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:
Maintains Duke and project specific training requirements. Keeps current with research updates by attending key external departmental meetings (i.e., Research Wednesday, RPN, additional training, etc.). Demonstrates resilience and is adaptive to change. Communicates with other study personnel as required for study implementation and routine problem resolution.

Type of Research:
Will be involved in research that may include both retrospective and prospective components. Study populations vary depending on the project working primarily with adult patients seen within Duke University Health System or its affiliates. Research may involve chart reviews, surveys, interviews, or longitudinal follow-up of participants.

Special skills:
This role requires strong organizational, data management, and regulatory compliance skills to ensure all study activities align with institutional policies, and GCP standards.

Work requires an Associate 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.

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

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunities without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

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