Duke University
 Durham, NC

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Responsible to the DOCR Research Practice Manager for the day-to-day operations of the DOCR Service Center coordinator team associated with the Service Center (Core) Site-Based Research participation in clinical research studies as an investigative site. Ensure that CRCs and designated research personnel are performing study activities in accordance with Good Clinical Practice (GCP), Duke policy and regulatory requirements using Standard Operating Procedures (SOPs) and periodic monitoring. Perform study conduct activities for clinical trials and other human participatory research studies to support the Service Center. Assist in providing operational and study conduct metrics/reports to RPM and Director. Review and reconcile Service Center data in accordance with Service Center SOPs. Contribute to Institutional and DOCR initiatives to engage research communities and bolster research engagement across community partners.

Work Performed

30% Management:

  • Responsibility to screen, interview, and hire clinical research professionals with RPM and Director input. Develop an individualized orientation plan with new staff and provide the level of oversight needed by the new staff member.
  • Conduct onboarding, training, and professional guidance for clinical research professionals, including navigation through the Tier Advancement process per DOCR and institutional guidelines. Maintain current training records and required certifications. Evaluate and implement professional development and/or training programs offered through DOCR (e.g., Research Professionals Network (RPN), Research Wednesdays) to encourage staff retention, continuous improvement, and development. Serve as an expert resource with regard to study conduct and is knowledgeable about other resources at Duke. Create a team environment with a culture that fosters communication and inclusion.
  • Assist with staff effort distribution, to ensure that staff are appropriately assigned studies based on volume and individual staff competency. Ensure that CRCs/CRNCs and other research staff are trained for new studies/projects. Conduct regular meetings with study coordinators and other research staff. Ensure that staff informed DOCR departmental and institutional activities, goals, and policies and procedures.
  • Conduct annual performance evaluations and performance improvement plans with staff; consulting with Human Resource Manager and RPM if needed.
  • Oversee the operations of studies and provide regular updates to the RPM and Director as needed. This may include study start up, enrollment, recruitment, closeout, continuing renewals, etc. Monitor the performance and progress of the CRCs/CRNCs and other research staff. Ensure that the CRCs/CRNCs and other research staff coordinate IRB submissions, participant recruitment, screening, consent and enrollment, data collection, safety reporting, drug accountability, and record retention as required. Keep current with research updates and oversee implementation of new policies and regulations among staff members.
  • Monitor compliance with institutional requirements and provide guidance to direct reports pertaining to quality data collection and capture, data flow plans, data security and provenance, and data quality assurance. Guide direct reports to resources as necessary for study compliance with data processes and policies (e.g., ISO, IRB).
  • Provide research metrics to RPM and Director in order to advise on high level decisions. Continuously identify methods and work with the RPM to improve Service Center and institutional procedures and policies.
  • Support Service Center operations by regularly reviewing a and reconciling staff tracking data and providing necessary reports to RPM and Director. Work with RPM, Director, and external CRU partners to assist with Service Level agreements and service estimates for new projects. Develop and implement solutions to improve the research and operational processes.
  • Contribute to and represent the institution in internal and external groups related to research or therapeutic area (e.g., institutional initiatives or committees). Uses advanced subject matter expertise in clinical research activities to solve complex problems. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
  • Demonstrate resilience, leadership, and actively facilitate change within the Service Centers.

30% Initiatives:

  • Serve as lead on delegated high-level initiatives that support DOCR and institutional goals of maintaining high quality clinical trials, establishing and supporting community partners in research, and ensuring equity, inclusivity, and diversity across research communities.
  • Lead multidisciplinary team meetings by establishing attendance lists, agendas, creating action items, and following up on action items.
  • Assist clinical research professionals in the development of participant recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions. Should be knowledgeable about SOM resources available to teams for assistance.
  • Serve as a resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem-solving related to clinical, logistical, financial and regulatory issues. Assist PIs, study coordinators and research staff in use of available subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.

40% Operations, and Study Conduct:

Participate in project work that could include but is not limited to: IRB submissions, participant recruitment, screening, consent and enrollment, data collection, safety reporting, drug accountability, and record retention. Conduct research coordination for Phase 1-4 clinical trials including drug, device, biologic, and behavioral interventions as well as other forms of human participatory research studies.

  • 20% Research Operations & Site Management:
    • Supervise, provide guidance, and conduct research operations for studies as assigned. This includes: regulatory and institutional policies and processes, screening, recruitment and retention, study monitoring, audit visits, participant and study level documentation, study visits, SOPs, specimen management, IND/IDE/ITP documentation, investigational product, and contracts and agreements.
    • Ensure that key personnel are properly trained and document training according to institutional and regulatory policies in a timely fashion.
    • Conduct internal quality assurance audits of specific studies and assist in preparation for external audits. Review and respond to audit reports, and develop and implement corrective action plans in a timely manner when problems are identified.
    • Serves as an expert resource to clinical research professionals and outside agencies with regard to study specific protocol requirements and problem solving related to clinical, logistical, financial and regulatory concerns.
    • Ensures that studies assigned are conducted in compliance with institutional requirements and policies. Acts as the primary contact during study startup and intervenes when study teams have a conflict with sponsors and/or CROs.
    • Monitor the status of start-up timelines for new studies. Monitor the progress of ongoing studies including enrollment, data collection, and close-out
  • 10% Safety and Ethics:
    • Monitor compliance with institutional requirements and provide guidance to direct reports pertaining to: developing and submitting documentation and information for IRB review, preparing and submitting documents needed for regulatory and safety reporting to sponsors and other agencies, identifying and documenting adverse event information, conducting and documenting consent, and developing consent documents and processes.
  • 10% Data:
    • Performs data audits on specific studies and provides corrective action as needed.
    • Assists with and provides guidance on the implementation of new technologies and data capture requirements across the DOCR Service Center and project teams.

Reporting Relationship:

The Assistant Research Practice Manager (ARPM) will report to the Research Practice Manager.

Required Qualifications at this Level

  • Education/Training:
    • Work requires completion of a Bachelor's degree. ACRP or SOCRA certification.
  • Experience:
    • Work requires a minimum of six years of related experience, with at least four years in a research setting.
    • A Master's degree may substitute for two years of related experience.
    • Preferred experience includes therapeutic clinical trials and community stakeholder engagement or outreach
  • Skills:
    • Work requires proficiency in Microsoft Office Suite including Teams, REDCap, EPIC, and Oncore. Preferred skills include, project management certification, Spanish language proficiency

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

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.