ASSISTANT RESEARCH PRACTICE MANAGER
Durham, NC, US, 27710
Be You.
Be Bold.
What You’ll Do:
- Participate in screening, interviewing, and hiring CRPs in collaboration with faculty and the RPM.
- Support onboarding, training, and advancement of CRPs in partnership with DOCR and SOM resources.
- Manage staff study assignments and effort distribution based on volume and competency.
- Conduct performance evaluations and improvement plans as needed.
- Oversee CRU study operations including initiation, recruitment, enrollment monitoring, and close-out.
- Provide study metrics and operational updates to the RPM.
- Partner with the RPM to enhance CRU processes, policies, and efficiency.
- Supervise study conduct, ensuring compliance with GCP, institutional standards, and regulatory requirements.
- Oversee screening, recruitment, retention, study visits, documentation, monitoring, and audit readiness.
- Support development of corrective action plans following internal or external audits.
- Guide teams in developing recruitment strategies and addressing enrollment barriers.
- Lead multidisciplinary research meetings and ensure follow-up on action items.
- Assist with IDS/ICS coordination and international regulatory documentation when required.
- Ensure proper submission and documentation for IRB activities, consent processes, safety reporting, and AE documentation.
- Provide expertise on ethical study conduct and regulatory expectations.
- Oversee data workflows, quality assurance, data security, and compliance with institutional data policies.
- Perform data audits and implement corrective actions when needed.
- Guide teams in implementing new data capture technologies.
- Support CRU teams with data-related planning, reporting, and return-of-results activities.
- Assist with documentation of scientific review processes.
- Support budgeting and negotiation efforts with study sponsors.
- Serve as a primary contact during study startup and help resolve conflicts with sponsors or CROs.
- Collaborate with CRU Financial Practice Manager and RPM on study feasibility and selection.
- Provide operational oversight to ensure protocol adherence and financial milestone tracking.
- Promote participation in DOCR career development programs.
- Keep teams updated on new regulations and institutional policies.
- Represent the CRU and Duke in internal or external working groups.
- Advance a collaborative, communicative, and solution-oriented culture.
- Lead change initiatives and foster continuous improvement across the CRU.
Choose Duke.
Ready to Make a Difference?
Anticipated Pay Range:
Duke University provides an annual base salary range for this position as USD $99,969.00 to USD $161,531.00. 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 goes beyond 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: https://hr.duke.edu/benefits/
Minimum Qualifications
Education
Work requires completion of an Associate 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. Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience. A Bachelor's degree may substitute for 2 years required experience.
Degrees, Licensures, Certifications
Work requires a minimum of eight years of related experience, with at least four years in a research setting. Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience. A Bachelor's degree may substitute for 2 years required experience.
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 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.
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh