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

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

data workflowsquality assurancedata securityperformance evaluationscorrective action plansstudy metricsenrollment monitoringaudit readinessbudgetingnegotiation

Soft Skills

collaborationleadershipcommunicationteam guidanceproblem-solvingorganizational skillsmultidisciplinary teamworktrainingmentoringstrategic planning

Certifications

ACRP certificationSOCRA certificationClinical Research Apprenticeship program