School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary
Responsible to the Clinical Research Unit (CRU) Director and School of Medicine (SOM) for oversight of all research activities related to study conduct within the CRU. Accountable for day to day CRU operations and people management. Ensure that clinical research professionals and investigators are appropriately trained and performing activities in accordance with good clinical practice, CRU standards, institutional policy, and regulatory requirements. Oversee and provide metrics/reports to institutional leadership on the previously mentioned activities.

Work Performed
Management and Institutional Responsibility
Oversee the operations of studies and provide regular updates to the CRU Director and School of Medicine leadership as needed. This may include study start up, enrollment, recruitment, closeout, continuing renewals, etc.
Manage staff effort distribution for the CRU to ensure that staff are appropriately assigned studies based on the volume of activity and individual staff competency.
Serve as an expert resource to all CRU study teams with regard to study conduct.
Actively encourage collaboration with SOM administration resources and offices.
Responsible for oversight or delegation of new employee identification process including screening, interviewing, and hiring clinical research professionals with faculty and department input.
Collaborate with Duke Office of Clinical Research (DOCR) and other School of Medicine (SOM) resources to conduct onboarding, training, and professional guidance for clinical research professionals.
Conduct annual performance evaluations, goal setting, and corrective action, as needed.
Serve as the Single Point of Contact for Tier Advancement, 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.
Establish and assign activities of other managers to accomplish goals of the institution and CRU.
Effectively make decisions based on analysis of data collectedvia clinical research management systems.
Continuously identify methods to improve CRU and institutional procedures and policies.

Research Operations

Oversee CRUs
Research activities and timelines as related to 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 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.
Should be knowledgeable about SOM resources available to teams for assistance.
Collaborate to develop and ensure CRU implementation of institutional SOPs, policies, and initiatives.
Conduct CRU quality assurance audits.
Oversee and participate in internal and external audits of CRU studies.
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.

Safety and Ethics
Oversee compliance with institutional requirements and serve as an expert resource at Duke 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.

Data
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.
Actively encourage study teams to connect with stakeholders (e.g ., statisticians) and institutional resources (e.g., ISO, IRB).
Coordinate with institutional leadership on initiatives and priority setting to ensure appropriate 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 CRU Financial Practice Manager (FPM) and SOM administration resources 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.
Should be knowledgeable about SOM resources available to teams for assistance.
Serve 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.
Ensure that studies within the CRU are co nducted in compliance with institutional requirements and policies.
Oversee how teams communicate with sponsors and/or 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 expertisein clinical research activities to solve complex problems across the CRU.
May develop and implement solutions at the institutional level to improve the research process.
Use expertise and acumen to influence change at the CRU level. Demonstrate resilience, leadership, and actively facilitate change for CRU.
Create a team environment with a c ulture that fosters communication.
Communicate effectively across the CRU regarding new policies,regulatory updates, and instit tional SOP changes.

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.

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.