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.

Occupational Summary

Responsible to the Research Practice Manager (RPM) for oversight of study conduct for research studies within the Innovation Collaboratory and Data Science clusters within the Heart Center Clinical Research Unit. Assists the RPM in the day to day management of CRU operations and people.

Ensures 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. Assists in providing operational and study conduct metrics/reports to RPM.

This is not a remote position.

Work Performed

Management and Institutional Responsibility

Screens, interviews, and hires clinical research professionals with faculty and RPM input.

Collaborates 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, including navigation through the Tier Advancement process.

Assists with staff effort distribution, for the assigned divisions or clusters, to ensure that staff are appropriately assigned studies based on volume and individual staff competency.

Conducts annual performance evaluations and performance improvement plans with staff; consulting with Human Resource Manager and RPM if needed.

For assigned division(s) or cluster(s), oversees the operations of studies and provides regular updates to the RPM as needed. This may include study start up, enrollment, recruitment, closeout, continuing renewals, etc.

Provides research metrics to RPM in order to advise on high level decisions.

Serves as an expert resource to assigned division (s) or cluster(s) with regard to study conduct and is knowledgeable about other resources at Duke.

Continuously identifies methods and works with the RPM to improve CRU and institutional procedures and policies.

Research Operations

Supervises and provides guidance on research operations for the studies within the assigned division(s) or cluster(s). 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.

Knowledgeable about SOM resources available to teams for assistance.

Minimum Qualifications

Education

Work requires completion of an associate's degree. ACRP or SOCRA certification preferred.

Experience

Work requires a minimum of eight years of related experience, with at least four years in a research setting. A bachelor'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 essential job 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.