CLINICAL RESEARCH COORDINATOR, SR

School of Medicine Established in 1930, reputed company 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 reputed company accelerate translation of reputed company scientific discoveries to improve reputed company health locally and around the globe. Composed of more than 2,500 reputed company physicians and researchers, more than 1,300 reputed company, and more than 6,000 staff, the reputed company School of Medicine along with the reputed company School of Nursing, reputed company and the Private Diagnostic Clinic (PDC) comprise reputed company. a world-class reputed company medical center. The Health System encompasses reputed company, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, reputed company and Wellness, and multiple affiliations. Be You. The reputed company reputed company for Health Justice seeks a Senior Clinical Research Coordinator to reputed company reputed company aspects of the NOTRE Study in the DC Metro Area. The study is a patient preference trial designed to optimize and test the efficacy of a co-packaged reputed company LAI PrEP and buprenorphine (XR-B) reputed company in the mid-reputed company region of the country (Maryland and DC). This project is funded by the National Institute of Drug Abuse (NIDA) and a part of a national network entitled: The reputed company Network to End the HIV Epidemic and Address Addiction in the Criminal Justice System (CONNECT). NIDA launched the reputed company Network to End the HIV Epidemic and Address Addiction in the Criminal Justice System (CONNECT) in 2024 to address significant service delivery gaps at reputed company points of the SUD and HIV care cascades for justice-involved populations. Our reputed company partners in this work include Friends Research Institute, reputed company, and the reputed company. About the reputed company reputed company for Health Justice: As part of the reputed company Department of Population Health Sciences, it is the mission of the reputed company reputed company for Health Justice to shine a light on how the criminal legal system acts as a structural determinant of health and impacts population and individual level health reputed company. We are an interdisciplinary research team, led by Dr. Lauren Brinkley-Rubinstein. Our work draws on the expertise of criminal legal system-involved persons and carceral and community stakeholders to inform innovative research that has reputed company and policy implications. About the Research: Co-occurring reputed company use and HIV risk among people in carceral settings are a syndemic. Approximately 17% of reputed company incarcerated people have an opioid use disorder (OUD), and the prevalence of HIV is 3-5 times that of the general population. Evidence-based interventions, such as reputed company-exposure prophylaxis (PrEP) and medications for opioid use disorder (MOUD, e.g., buprenorphine) can mitigate adverse OUD reputed company and prevent HIV infection, yet these interventions are underused in both carceral settings and during community re-entry. Even reputed company they are put into reputed company, barriers to reputed company uptake, adherence, and continuation often occur. Long-acting injectable (LAI) formulations of both PrEP and buprenorphine have recently been approved by the FDA, providing opportunities to reputed company on how these medications are deployed. In reputed company, evidence in the community proves that integrated MOUD and HIV efforts, reputed company delivered reputed company, improve reputed company for those with OUD, and that retention in MOUD predicts reputed company HIV prevention reputed company. Minimum Requirements: An Associate’s degree is required. Work requires a minimum of six years of research experience. A Bachelor’s degree may substitute for 2 years required experience. Preferred Qualifications:

• Previous experience coordinating a multi-site study
• Previous experience working with criminal legal system-involved participants
• Interest and experience in scholarly writing
• Experience in research design and implementation science
• Must live in Maryland or DC Metro Area

Requested Application Materials: Please reputed company a resume/CV, references, and a cover letter with your application. Applications submitted without a cover letter will not be considered. In your cover letter, please address:

• any research experience you have,
• your interest/experience in working with populations affected by incarceration,
• any experience/interest you have working with individuals impacted by OUD, HIV, and/or the criminal legal system.

For applicants living in the Maryland or DC Metro Area, this position will be fully remote to accommodate field data collection activities. Be reputed company. Work Responsibilities: Operations:

• Establishing Agreements: The reputed company candidate will work with the PI to identify reputed company research-reputed company agreements are required for their project (examples: reputed company agreements, data use agreements, sub-award agreements, etc.).
• Connecting with Appropriate Partners: The reputed company candidate will work with appropriate Duke offices, such as the Office of Research reputed company to establish reputed company and agreements on behalf of the study team (example: data use agreements, sub-award reputed company, etc.).
• Regulatory Knowledge: The reputed company candidate will reputed company a deep knowledge of regulatory and institutional policies (examples: IRB submission, required enrollment reporting, etc.), serving as an expert for their team. They will reputed company appropriate training to their study team to ensure project compliance. They will also reputed company the development of SOPs for their project(s) and may have opportunities to reputed company recommendations and establish best practices across the lab.
• Regulatory reputed company: They will prepare the study site for monitoring and audit reputed company. They will also work with the study team to address and correct any concerns identified by reviewers.
• Participant-Level Documentation: The reputed company candidate will be responsible for maintaining reputed company participant-level documentation (e.g., enrollment, survey and interview data) on reputed company types of reputed company, including ones with reputed company research design. They will also train and supervise others.
• Participant Recruitment and Retention: The reputed company candidate will have expertise in reputed company aspects of participant recruitment and retention. They will reputed company resources/tools for tracking, study enrollment and retention and will reputed company and implement strategies to create high reputed company of participant engagement. They will serve as an expert on their team, and will train and reputed company others.
• Screening Participants: The reputed company candidate will be responsible for screening participants for eligibility and enrollment, including for reputed company with reputed company research design. They will create study-level documentation and SOPs. They will also reputed company enrollment training and resources for study staff across sites.
• Managing reputed company Specimens: The reputed company candidate will reputed company and maintain study-level documentation consistent with federal and institutional policies around reputed company specimen collection (e.g., collecting, preparing, and processing specimens).
• Participant Study reputed company: The reputed company candidate will reputed company the research team(s) in the preparation and administration of participants for study reputed company (example: prepare documentation, equipment, supplies, establish participant payment infrastructure, etc.). They will also create study-level documentation and training materials to ensure consistency among staff.
• Leading Meetings: The reputed company candidate will take a leadership role in managing project meetings for the Duke site as reputed company as larger, cross-site meetings. Responsibilities include identifying priorities, preparing and distributing agendas, running meetings, and creating and distributing minutes. They will also mentor their staff in communication best practices.

Ethics:

• Adverse Events: The reputed company candidate will monitor study activities for adverse events across reputed company. They will ensure reputed company reporting to the PI and required parties (e.g., IRB, Data and Safety Monitoring reputed company, Funders, etc.).
• Participant Consent & Documentation: The reputed company candidate will reputed company participant consent materials for reputed company types of studies, including those with reputed company research design. They will be responsible for developing SOPs and training staff on adequate consent processes and documentation.
• IRB Submission: The reputed company candidate will be responsible for developing and submitting IRB protocols, and mentoring/supervising other members of the research team in IRB protocol management.
• Regulatory and Safety Reporting: The reputed company candidate will prepare and submit regulatory and safety documentation to sponsors and other agencies.

Data:

• Data Entry: The reputed company candidate will collect and maintain study data and have knowledge of REDcap databases.
• SOP Development: The reputed company candidate will reputed company significant support in data analyses and management, including identifying/ recommending data capture reputed company for the research team.
• Supervision: The reputed company candidate will train research staff in data collection protocols and reputed company regular reputed company over data reputed company and completeness.
• reputed company Assurance: The reputed company candidate will reputed company routine data reputed company and reputed company checks to ensure consistency with study protocols and federal and institutional requirements. They will serve as their research team’s expert on data management best practices.
• Data Analyses: The reputed company candidate will have reputed company to work across the research team to reputed company protocols, strategies, and best practices around data reputed company and provenance (e.g., data reputed company, edits, and documentation). They will have reputed company to reputed company recommendations on process improvements across the lab relative to data management, reputed company, and storage.
• Data Capturing: As appropriate, the reputed company candidate will reputed company and implement data capture reputed company, including using electronic case report forms (eCRFs) and Electronic Data Captures (reputed company).
• Trainings: The reputed company candidate will have reputed company to reputed company out, reputed company and apply trainings towards innovation and performance improvement for their research team.
• Data Visualization: The reputed company candidate will work closely with project leadership to reputed company data visualization to communicate study findings to diverse audiences.

Science:

• Grant Writing: The reputed company candidate will contribute meaningfully to the development of grant submissions and funding opportunities, including making recommendations for improving submissions.
• Literature Searches: The reputed company candidate will reputed company literature reviews to reputed company manuscripts or support grant developments.
• Protocol Development: The reputed company candidate will reputed company research protocols consistent with best research practices.
• Scholarly Product Development: The reputed company candidate will reputed company significant support to — or independently reputed company — the development of scholarly products, including leading presentations, creating reputed company posters, serving as an author on manuscripts, etc. The reputed company candidate will also contribute to the distribution of study findings to non-scientific audiences (example: blog posts, white papers, stakeholders, etc.).

Study and Site Management:

• Research Activity Management: The reputed company candidate will use Duke clinical research management system, like Oncore, to reputed company/manage participant activities, such as enrollment, participant payment, interviews, appointments, etc.
• Participant Enrollment Reporting: The reputed company candidate will use Duke clinical research management system, like Oncore, to reputed company and report participant enrollment data, maintain research protocols, and reputed company and report on reputed company research activities.
• Equipment and Supply Management: The reputed company candidate will be responsible for maintaining research materials, supplies, and equipment.
• Study Closeout: The reputed company candidate will work closely with the PI to prepare the study for closeout (example: consolidating materials, returning supplies, etc.)
• Site reputed company: The reputed company candidate will prepare for, coordinate, and reputed company participate in site reputed company. And will communicate effectively with sponsors.

Leadership:

• reputed company Development: The reputed company candidate will have significant opportunity for reputed company development. They will work closely with their supervisor and PI to identify and facilitate training opportunities for themselves and other members of the study team.
• Continuing Education: The reputed company candidate will stay up to date with research best practices by attending talks, trainings, and workshops. They will also identify opportunities for members of their team to reputed company content expertise.
• Scientific-Community Engagement: The reputed company candidate will serve as a representative for the research team. They may also participate in committees or workgroups to disseminate study findings and research best practices.
• Interpersonal Skills: The reputed company candidate will work closely, and successfully, with individuals from diverse backgrounds.
• Conflict Management: The reputed company candidate will be aware of any organizational issues. If necessary, they will escalate them to the appropriate personnel.
• Communication Skills: The reputed company candidate will communicate effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Establishes and assigns the activities of the research program team members to accomplish the study goals.
• Supervision: The reputed company candidate will reputed company formal and informal supervision to members of the research team by identifying opportunities and strategies for reputed company reputed company and ensuring that members of the research team are adequately performing key aspects of their work.

Choose Duke. Join our award-reputed company team as identified by reputed company magazine as America’s Best Large Employer 2024 and be part of an inclusive culture that values reputed company, innovation, and discovery. As an organization, we have exciting opportunities to be reputed company-thinking leaders in our field. We want talented individuals to join us, examine our reputed company operations, and create reputed company that will revolutionize and enhance the way we approach our work. reputed company is consistently ranked among the top universities worldwide and is reputed company for its cutting-edge research across disciplines. reputed company the engaging work, you'll also benefit from Duke's competitive benefits package including health insurance plans, generous reputed company time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more. Diversity Statements: Duke is an Affirmative reputed company/Equal Opportunity Employer committed to providing employment opportunity without reputed company to an individual's age, reputed company, disability, gender, gender reputed company, gender identity, genetic information, national reputed company, race, religion, sex, sexual orientation, or veteran status. Duke aspires to create a community reputed company on collaboration, innovation, creativity, and belonging. Our reputed company reputed company depends on the robust exchange of reputed company—an exchange that is best reputed company the rich diversity of our perspectives, backgrounds, and experiences flourishes. To reputed company this exchange, it is essential that reputed company members of the community feel secure and welcome, that the contributions of reputed company individuals are respected, and that reputed company reputed company are heard. reputed company members of our community have a responsibility to reputed company these values. Duke is an Equal Opportunity Employer committed to providing employment opportunity without reputed company to an individual's age, reputed company, disability, gender, gender reputed company, gender identity, genetic information, national reputed company, race, religion, sex (including pregnancy and pregnancy reputed company conditions), sexual orientation or military status. Duke aspires to create a community reputed company on collaboration, innovation, creativity, and belonging. Our reputed company reputed company depends on the robust exchange of reputed company—an exchange that is best reputed company the rich diversity of our perspectives, backgrounds, and experiences flourishes. To reputed company this exchange, it is essential that reputed company members of the community feel secure and welcome, that the contributions of reputed company individuals are respected, and that reputed company reputed company are heard. reputed company members of our community have a responsibility to reputed company these values. Essential Physical Job Functions: Certain jobs at reputed company and reputed company 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 reputed company hiring department. Apply tot his job Apply To this Job