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.

To embody Duke’s longstanding vision of improving population health and create a transdisciplinary setting for research and education, the University’s Board of Trustees approved the Department of Population Health Sciences in the School of Medicine in May 2017. The department’s creation brought together faculty and operational staff in behavioral science, epidemiology, health economics, health services research and policy, and implementation science. The department includes 51 faculty members, 59 scholars with secondary appointments, and 75 staff members.

The Research Practice Manager (RPM) is responsible for the oversight of all research activities related to study conduct within the Department of Population Health Sciences’ (DPHS) Clinical Research Unit (CRU) including direct supervision of research program leaders and other research staff as required. The position also ensures that the DPHS research staff, trainees, and investigators are appropriately trained and performing activities in accordance with good clinical practice, CRU standards, Department and Institutional policy, and regulatory requirements. The position oversees and provides metrics and reports to Department and Institutional leadership on essential CRU activities.

Specific duties include the following:

Management and Institutional

Oversee the operations of studies and provide regular updates to the Vice Chair of Research and CRU Director, Chief Administrative Officer, and School of Medicine leadership as needed.

With Research Program Leaders (RPLs), monitor staff effort distribution for the CRU to ensure that staff are appropriately assigned to studies based on their experience/competence and classification.

Serve as an expert resource to all CRU study teams with regard to study conduct.

Actively encourage collaboration with SOM administration resources and offices.

Oversight of professional research staff hiring processes, including the identification process, screening, and interviewing, in collaboration with the Department’s HR Director and other Department resources.

Collaborate with Duke Office of Clinical Research (DOCR) and other School of Medicine (SOM) resources to conduct onboarding, training, and professional guidance for research professionals, including staff, trainees, and investigators.

Conduct annual performance evaluations, goal setting, and corrective action for direct reports and support performance management process for the research staff organization.

Serve as the primary point of contact for the Tier Advancement process, including ensuring that staff are eligible, disseminating results, educating new hires on the process, and other duties as required.

Responsible for appropriately requesting and managing clinical research system access for staff.

Continuously identify methods to improve CRU and department procedures and policies.

Monitors research staff, trainee, and investigator compliance with required trainings, including Responsible Conduct of Research (RCR) and Stewardship and Compliance for Research Investigators (SCRI) trainings.

Maintains the Department’s Scholarly Culture and Accountability (SCAP) document and ensures and tracks that research staff, trainees, and investigators have attested to the SCAP.

Serves as a delegate for the Department’s Research Quality Management Project Plan in the REDCap system, maintains the plan with accurate and updated details, and ensures Department meets Research Quality milestones and deadlines.

Research Operations

Ensure research staff members are following appropriate research activities to meet requirements for regulatory and institutional policies and processes, screening, recruitment and retention, study monitoring, audit visits, participant and study level documentation, study visits, specimen management, and contracts and agreements.

Ensure that key personnel are properly trained, and the training is documented, according to institutional and regulatory policies in a timely fashion.

Assist clinical research professionals in the development of participant recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.

Serve as a resource to research staff, trainees, and investigators about SOM resources available to teams for assistance.

Collaborate to develop and ensure CRU implementation of institutional standard operating procedures (SOPs), policies, and initiatives.

Oversee and participate in internal and external audits of CRU studies, including CRU quality assurance audits.

Review and respond to audit reports and develop and implement corrective action plans in a timely manner when problems are identified.

Lead multidisciplinary team meetings by establishing attendance lists, agendas, creating action items, and following up on action items.

Serves as the primary point of contact for faculty effort needs and research staff effort gaps and facilitates matchmaking as appropriate.

Identifies need to hire additional research staff for funded research programs and supports the hiring process and supervision of new research staff, as appropriate.

Safety and Ethics

Oversee compliance with institutional requirements and serve as an expert resource at Duke pertaining to the following: 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.

Data Management

Oversee compliance with institutional requirements and serve as an expert resource at Duke pertaining to quality data collection and capture, data flow plans, data security and provenance, and data quality assurance.

Coordinate with institutional leadership on initiatives and priority setting to ensure appropriate data quality assurance (QA) processes.

Responsible for the implementation, adoption, and monitoring of new research technologies or systems (e.g. Oncore, Maestro Care, etc.) and data capture requirements across the CRU.

Scientific Concepts

Oversee the CRU review processes to ascertain scientific integrity, impact, and inclusion in the departmental CRU research study portfolio.

Ensure appropriate documentation of scientific review processes, including decisions made by faculty scientific reviewers/review committees.

Site and Study Management

Collaborate with Department and SOM administration to evaluate the feasibility of new studies, including staffing and budgetary requirements, clinical and logistical considerations, and competing studies.

Work with financial staff to develop and negotiate budgets with sponsors.

Serve as an expert resource to clinical research professionals and outside agencies about study specific protocol requirements and problem solving related to clinical, logistical, financial and regulatory concerns.

Ensure that studies within the CRU are conducted in compliance with institutional requirements and policies.

Oversee how teams communicate with sponsors and/or clinical research organizations (CROs).

Leadership and Professionalism

Keep current with research and institutional updates and oversees necessary implementation among CRU staff members.

Evaluates 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.

Participate or lead institutional initiatives or committees and/or serve in a leadership capacity in professional organizations.

Use advanced subject matter expertise in clinical research activities to solve complex problems across the CRU.

Use expertise and acumen to influence change at the CRU level. Demonstrate resilience, leadership, and actively facilitate positive change for the CRU.

Create a team environment with a culture that fosters collaboration and open communication.

Communicate effectively across the CRU regarding new policies, regulatory updates, and institutional SOP changes.

Additional Duties

Serves as a mentor and coach for Research Program Leaders and other research staff professionals.

Performs additional duties related to research oversight, operations, and compliance as needed based on feedback from Department and Institutional leadership.

Minimum Qualifications

Education

Work requires completion of a Bachelor's degree. ACRP or SOCRA certification preferred.

Experience

Work requires a minimum of eight years of related experience, with at least five years in a research setting. A Master's degree may substitute for two years of related experience.

DPHS Diversity Statement
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.

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.