Clinical Research Specialist, Sr.

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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses 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 multiple affiliations.

Be You.

You will help support the entire lung transplant portfolio, which includes primarily repositories/specimen collection and treatment trials.

Minimum Requirements:

• • Work requires an 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

Preferred Qualifications:

• Specimen processing experience is a plus

Other Requirements:

• Necessary licenses, registrations, certifications, equipment used, and general information (ex: on-call, standby, inclement weather)

This position is (insert options below).

• Onsite. The work is performed on-site or at a designated assignment location.

Be Bold.

Operations:
Knowledgeable in regulatory and institutional policies and processes. Applies knowledge to assist with study documentation, protocol submissions, and standard operating procedures (SOPs). Assists with study level documentation and approvals for international studies. 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 minimal risk (e.g., questionnaire, data registry, scripted) studies. 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 minimal risk 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. Prepares documents, equipment, supplies, etc. in compliance with the protocol. Assists with the conduct and documentation of minimal risk study visits and scripted testing or interviews. Participates in study team meetings.

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 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, develops and submits documentation and information for IRB review. Assist with the compilation of documents needed for regulatory and safety reporting to sponsors and other agencies.

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 minimal risk 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. Follows requirements for depositing data into an appropriate repository and meta-data specifications for data sharing. With guidance, locates and follows repository-specific requirements to submit study data for sharing. Follows requirements for use of data standards for developing research databases. (E.g. IDC 10, CDISC, MedDRA, and WHODrug). 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. Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators. 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 minimal risk studies in clinical research management system. Records basic protocol information in clinical research management system. For studies with simple supplies or equipment, ensures 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

Choose Duke.

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $23.00 to USD $34.50. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. 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. Learn more at:

Equal Opportunity Employer: Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions:

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: View email address on aiapply.co; phone: View phone number on aiapply.co).