Clinical Research Coordinator, 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.

Duke University Department of Obstetrics and Gynecology has an immediate opening for a Sr. Clinical Research Coordinator in their Urogynecology division. Urogynecology is a medical discipline focused on pelvic floor issues including vaginal prolapse, bladder control issues, bowel control issues, and recurrent urinary tract infections. Given the breadth of our research program, we are looking to hire a research team lead to oversee and manage the research coordinator team, as well as day-to-day operations and studies. We are specifically looking for a highly motivated, team-oriented individual to integrate into several NIH-funded and industry-funded trials. This is an in-person position which will require rotating days between our two clinical offices (one in Durham and one in Raleigh).

Minimum Requirements:

Education/Training

Work requires an Associate's degree

Experience

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

Be Bold.

Position Description:

Operations:

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.

Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes.

Oversees the management and documentation of investigational products (IP) for multiple study teams/research program.

Serves as an IP expert resource for study teams. Designs, implements, and optimizes methods for handling IP. Provides direction to multiple study teams/research program to prepare for study monitoring and audit visits.

Provides oversight, training, and expertise to multiple study teams/research program regarding participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require DUHS billing.

Serves as an expert resource for multiple study teams/research program for participant retention.

Liaises with other resources at Duke to optimize retention rates. For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals.

Provides training. Screens participants for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training in screening activities to multiple study teams.

Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s). Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.

Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). May train or oversee others. Serves as an expert resource and trainer to multiple study teams/research program for preparing and conducting complex study visits, developing tools, and implementing operational plans.

Prepares for and leads effective facilitation of research program meetings in order to achieve objectives. Ensures good communication within the research program, including mentoring staff to improve communication strategies. Ethics:

Ensures that multiple study teams/research program team members are appropriately identifying and documenting adverse event information.

Provides oversight and training to multiple study teams/research program team members who conduct and document consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care.

May serve as an expert resource with regard to conducting and documenting consent including liaising with and being knowledgeable about other resources at Duke.

Develops consent plans and documents for participants in a variety of studies. May train or oversee others. Provides oversight and training to multiple study

teams/research program team members who develop and submit documentation and information for IRB review. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others. Data:

Enters and collects research data. Develops research data entry or collection tools. May provide oversight or training to study team members collecting or entering research data.

Ensures accuracy and completeness of data for all studies, including those that are greater than minimal risk or complex in nature. Recognizes data quality trends and escalates as appropriate.

May develop tools for, and train others in, data quality assurance procedures. Follows required processes, policies, and systems to ensure data security and provenance.

In addition, recognizes and reports security of physical and electronic data vulnerabilities. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant.

Develops reports on study progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders. Science:

Assists with or contributes to the development of funding proposals. Develops elements of research protocols using scientific proposals from the PI.

Demonstrates a basic understanding of the elements of research study designs.

Contributes to the development of scientific publications or presentations. Serves as an author on poster presentations or publications. Study and Site Management:

Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs.

Oversees activities related to site visits. Uses clinical research management system and its reports to manage research participants' activities, calendars,

tracking/marking of financial milestones, and all aspects of study visits. Uses required EHR functionalities to manage participants and study visits. May train others.

Oversees use of systems and system reports to manage research protocol activities and maintaining current protocol information.

Makes feasibility recommendations for multiple study teams/research program.

Develops and oversees processes to determine participation in trials.

Oversees management of resources (staff, supplies, equipment) for multiple study teams/research program.

May manage the budget for research studies. For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies.

Oversees implementation of operational plans across multiple study teams or sites.

Develops and implements closeout procedures for multiple studies across multiple teams. Leadership:

Encourages staff to take part in professional development opportunities. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job.

May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research.

Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.

Develops and implements solutions that work within the existing leadership or organizational structure.

Actively facilitates and leads multiple study teams' adoption of change in their working environment. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams.

Communicates 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.

Choose Duke.

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $69,362.00 to USD $110,658.00. 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 goesbeyond 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 oncollaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideasan 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: ...; phone: ...).