This Position is Fully Grant Funded

School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

CLINICAL RESEARCH SPECIALIST, SENIOR

Type of Research

The Duke Vaccine and Trials Unit (DVTU), as part of the Human Vaccine Institute, is a consortium of investigators and study team members committed to conducting clinical investigations related to the control and prevention of infectious disease. In addition to vaccine and treatment evaluations, the DVTU also conducts antimicrobial pharmacokinetic trials and epidemiologic investigations. Unit studies have ranged from Phase 1 to Phase 4 investigations and have included infants, children, adolescents, adults, pregnant women, and the elderly as participants.

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 and train others in these tasks. Describe the various steps involved in handling IP. Assist with management of Investigational Products (IP) including arrival, storage, handling including requesting requisitions, inventory, and reordering 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 minimal risk studies. May conduct consent for studies with greater than minimal risk, under the supervision of a CRC or CRNC. Prepare for study monitoring and study audit visits. Collect, prepare or process adverse event information under supervision. Provide input for adverse event reports Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.

Ethics:

Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications. 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. Assist in investigating incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Follow SOPs for data QA.

Science:

Conduct literature reviews under the direction of the CRC, CRNC, or PI Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.

Leadership:

Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. May serve as mentor to other staff. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain training requirements and develop solutions to proactively ensure unit, department, division's compliance with training requirements.

Study and Site Management:

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. Prepare items for site initiation visits. Participate in sponsor required training Prepare for closeout and document storage

Communication:

Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. Participate in study team meetings. Respond to routine questions related to study protocol and refer more complex questions to others as appropriate. Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.

Special Skills

Strong verbal and written communication skills required. Familiarity with Duke systems preferable but not required. Microsoft Office skills (Outlook, Word, Excel, PowerPoint) are necessary; additional skills in database management and electronic data capture systems (e.g., Access, Redcap) are preferred but not required.

Required Qualifications at this Level

• Education/Training: Work requires an Associate's degree.
• Experience: One year of relevant experience. A Bachelor's degree may substitute for required experience.
• Skills: Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

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.