Assist Research Practice Manager

Role Overview

• 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
• 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
• Assist with documentation of scientific review processes
• Support budgeting and negotiation efforts with study sponsors
• Collaborate with CRU Financial Practice Manager and RPM on study feasibility and selection
• 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

Requirements

• completion of an Associate degree
• ACRP or SOCRA certification preferred
• 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

Tech Stack

• Google Cloud Platform

Benefits

• comprehensive and competitive medical and dental care programs
• generous retirement benefits
• a wide array of family-friendly and cultural programs to eligible team members