CLINICAL RESEARCH COORDINATOR

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.

Occupational Summary:

We are an accredited human tissue biorepository housed in the Department of Pathology, directed by a Duke School of Medicine Faculty Member.  The biorepository is funded to support biomedical research at Duke University and on behalf of the National Cancer Institute.  The individual hired will be responsible for participating in or leading day-to-day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. This is an exciting position in biomedical science with opportunities for career advancement.  We seek enthusiastic team members looking to advance their scientific careers.

Work Performed:

This position will serve as CHTN CRC, with the following responsibilities:

Operations:

Screen participants for minimal risk studies.  May screen participants for studies with greater than minimal risk, under supervision. Maintain subject level documentation for minimal risk studies, or for other studies under direction. Schedule participants and conduct visits for minimal risk studies independently. Collect, prepare, process, ship, and maintain inventory of research specimens.  Collaborate to maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Conduct and document consent for participants in a variety of studies independently assist with addressing and correcting findings from study monitoring and study audit visits. Collect, prepare or process adverse event information under supervision. Complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) under supervision.  Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.

Ethics:

 Recognize when patients are having difficulties with this distinction. Make recommendations regarding how to improve communications to help patients and staff understand the distinction. Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations. Understand that the safety of research participants is a priority.  Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial

Data:

 Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance.  Enter data accurately.  Score tests and measures according to protocol, and appropriate to role. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. Use required processes, policies, and systems to ensure data security and provenance. Recognize and report vulnerabilities related to security of physical and electronic data.  Assist in investigating incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Follow SOPs for data QA. Recognize when data agreements are necessary

Leadership:

Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process.  Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements.

Study and Site Management:

Collect information to determine appropriate feasibility, recruitment and retention strategies. Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately.  Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate.  Assist with study budgets. Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Media policy, etc.).  Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Take part in site initiation/closeout visits as directed. Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Take part in or lead closeout and document storage activities

Communication:

Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. Prepare for and lead team meetings. Recognize when others need to be brought into the conversation and escalate appropriately. Expand on the ideas of peers or team members.  Take an active role in including others in decision-making.

Type of Research

This position supports the Duke Biospecimen and Repository and Processing Core (BRPC), within the Department of Pathology as well as other collaborators in the Pathology Department.  The individual hired will screen and consent patients to the Biobanking protocol, track milestones for a 5-year grant, and assist with any required regulatory activities. 

The employee will be expected to carry a pager outside of their regular working hours, including weekends and holidays, based on a rotating schedule with the rest of the team.

Special Skills

Experience with bio-banking and specimen collection and handling is preferred but not required. Strong computer skills for data acquisition and entry are required.  Excellent verbal and written communication is essential.

Minimum Qualifications

Education:

Completion of an Associate’s degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination)

Experience:

Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. 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 provision for requests for reasonable accommodation will be provided by each hiring department.

Completion of an Associate's degree

Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.

Duke is an Affirmative Action/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, sexual orientation, or veteran 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 essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.