Clinical Research Project Leader

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.

 We are seeking a Clinical Research Project Leader to lead all aspects of the PIERS study for the North Carolina site. As part of the Duke University Department of Population Health Sciences, it is the mission of the Bellwether Collaborative for Health Justice to shine a light on how mass incarceration drives inequality in the US and impacts the social determinants of health at the individual and community levels. We are an interdisciplinary research team, led by Dr. Lauren Brinkley-Rubinstein. Our work draws on the expertise of justice-involved persons, corrections staff, and community stakeholders to inform innovative research that aims to eliminate health disparities, understand and address the social determinants of health of justice-involved persons, and contribute to policy change in the areas of criminal justice reform and mass incarceration.

The PIERS study is part of the Justice Community Opioid Innovation Network (JCOIN) and is a collaboration with research partners at the University of North Carolina at Chapel Hill, Brown University, Temple University, and the University of Rhode Island.

The PIERS Study is a randomized clinical trial, the main objective of which is to enhance interorganizational coordination between community supervision departments and community-based treatment providers to facilitate engagement in the continuum of evidence-based care for individuals under community supervision (e.g., probation, parole) with opioid use disorder (OUD). The PIERS study focuses on the integration of medications for opioid use disorder (MOUD) and peer support specialists into OUD treatment plans for these individuals.

OUD and associated overdose deaths have risen at an alarming rate in recent years in the United States. More than 50% of incarcerated individuals have a history of substance use, and over 200,000 individuals with opioid dependence pass through the U.S. criminal legal system annually. An estimated one in 55 adults under community supervision have a substance use disorder, and individuals with a history of incarceration have a significantly higher risk of dying from overdose, particularly in the first two weeks after release when individuals are at greater risk of an unintentional fatal overdose. The PIERS study aims to address gaps in OUD treatment and services in criminal legal settings by facilitating linkage to care to improve measures in the OUD treatment cascade.

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:

Has prior experience managing complex research projects (ideal candidate will have worked on at least one randomized control trial)

Strong preference will be given to persons living in Brunswick County (or surrounding counties)

Has experience with (or a strongly expressed interest) in working with individuals impacted by the criminal legal systems

Requested Application Materials:

Please provide 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.

For applicants living in or near Brunswick County,  this position will be fully remote to accommodate field data collection activities.

For applicants living in/near the Triangle, this position is hybrid, working on-site for a minimum of two days weekly, and must reside in the state of NC.

Be Bold.

 Work Responsibilities:

Operations:

Establishing Agreements: The hired candidate will work with the PI to identify when research-related agreements are required for their project (examples: independent contractor agreements, data use agreements, sub-award agreements, etc.).

Connecting with Appropriate Partners: The hired candidate will work with appropriate Duke offices, such as the Office of Research Contracts to establish contracts and agreements on behalf of the study team (example: data use agreements, sub-award contracts, etc.).

Regulatory Knowledge: The hired candidate will develop a deep knowledge of regulatory and institutional policies (examples: IRB submission, required enrollment reporting, etc.), serving as an expert for their team.  They will provide appropriate training to their study team to ensure project compliance. They will also lead the development of SOPs for their project(s) and may have opportunities to provide recommendations and establish best practices across the lab.

Regulatory Oversight: They will prepare the study site for monitoring and audit visits. They will also work with the study team to address and correct any concerns identified by reviewers. 

Participant-Level Documentation: The hired candidate will be responsible for maintaining all participant-level documentation (e.g., enrollment, survey and interview data) on all types of projects, including ones with complex research design. They will also train and supervise others.

Participant Recruitment and Retention: The hired candidate will gain expertise in all aspects of participant recruitment and retention. They will develop resources/tools for tracking, study enrollment and retention and will develop and implement strategies to create high levels of participant engagement. They will also have opportunities to train others.

Screening Participants: The hired candidate will be responsible for screening participants for eligibility and enrollment, including for projects with complex research design. They will create study-level documentation and SOPs. They will also provide enrollment training and resources for study staff across sites.

Managing Human Specimens: The hired candidate will develop and maintain study-level documentation consistent with federal and institutional policies around human specimen collection (e.g., collecting, preparing, and processing specimens).

Participant Study Visits: The hired candidate will lead the research team(s) in the preparation and administration of participants for study visits (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 hired candidate will take a leadership role in managing project meetings for the Duke site as well 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 hired candidate will monitor study activities for adverse events across projects. They will ensure timely reporting to the PI and required parties (e.g., IRB, Data and Safety Monitoring Board, Funders, etc.).

Participant Consent & Documentation: The hired candidate will develop participant consent materials for all types of studies, including those with complex research design. They will be responsible for developing SOPs and training staff on adequate consent processes and documentation.

IRB Submission: The hired 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 hired candidate will prepare and submit regulatory and safety documentation to sponsors and other agencies.

Data:

Data Entry: The hired candidate will collect and maintain study data.

SOP Development: The hired candidate will provide significant support in data analyses and management, including identifying/ recommending data capture methods for the research team.

Supervision: The hired candidate will train research staff in data collection protocols and provide regular oversight over data quality and completeness.

Quality Assurance: The hired candidate will provide routine data oversight and quality 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 hired candidate will have the opportunity to work across the research team to develop protocols, strategies, and best practices around data security and provenance (e.g., data source, edits, and documentation).  They will have the opportunity to make recommendations on process improvements across the lab relative to data management, security, and storage.

Trainings: The hired candidate will have the opportunity to seek out, integrate and apply trainings towards innovation and performance improvement for their research team.

Data Visualization: The hired candidate will work closely with project leadership to develop data visualization to communicate study findings to diverse audiences.

Science:

Literature Searches: The hired candidate will lead literature reviews to develop manuscripts or support grant developments.

Protocol Development: The hired candidate will develop research protocols consistent with best research practices.

Scholarly Product Development: The hired candidate will provide significant support to — or independently lead — to the development of scholarly products, including leading presentations, creating academic posters, serving as an author on manuscripts, etc. The hired 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 hired candidate will use Duke clinical research management system, like Oncore, to track manage participant activities, such as enrollment, participant payment, interviews, appointments, etc.

Participant Enrollment Reporting: The hired candidate will use Duke clinical research management system, like Oncore, to track and report participant enrollment data, maintain research protocols, and track all research activities.

Equipment and Supply Management: The hired candidate will be responsible for maintaining research materials, supplies, and equipment.

Study Closeout: The hired candidate will work closely with the PI to prepare the study for closeout (example: consolidating materials, returning supplies, etc.)

Site Visits: Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors.

Leadership:

Professional Development: The hired candidate will have significant opportunity for professional 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 hired 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 gain content expertise.

Scientific-Community Engagement: The hired 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 hired candidate will work closely, and successfully, with individuals from diverse backgrounds.

Conflict Management: The hired candidate will be aware of any organizational issues. If necessary, they will escalate them to the appropriate personnel.

Communication Skills: Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Choose Duke.

 For best consideration, apply by October 17, 2024.

 Join our award-winning team as identified by Forbes magazine as America’s Best Large Employer 2024 and be part of an inclusive culture that values excellence, innovation, and discovery. As an organization, we have exciting opportunities to be forward-thinking leaders in our field. We want talented individuals to join us, examine our current operations, and create innovative solutions that will revolutionize and enhance the way we approach our work.

 Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines.

Beyond the engaging work, you'll also benefit from Duke's competitive benefits package including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.

Diversity Statements:

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.

The Department of Population Health Sciences aspires to create a community built on collaboration, innovation, creativity, equity, and inclusivity of others without biases or prejudice of any kind. Our collective success depends on a robust exchange of ideas - an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, we are committed to diversity in the staff and faculty we hire, the policies we create, and the decisions we make.

NOTE TO EXTERNAL JOB APPLICANTS: We are pleased that you are exploring employment opportunities with Duke School of Medicine. If you need an accommodation to complete the application and/or interview process, please submit a Reasonable Accommodations Request form. Allow for up to 5 days for a response. More information is available at https://access.duke.edu/visitors-patients/. 

In the Bellwether Collaborative for Health Justice, we look for a diverse pool of applicants including those from historically marginalized groups —  people with incarceration histories, people with disabilities, women, people who are lesbian, gay, bisexual, transgender,  gender non-conforming, people with lived experiences of addiction and mental health conditions, people of color, first and second generation college students, first and second generation immigrants, veterans, and people from different socioeconomic backgrounds.

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.