ASSIST RESEARCH PRACTICE MANAGER
Requisition Number 400679582
Auto req ID 50443BR
Location Durham
Duke Entity MEDICAL CENTER
Department Name Onc SBR Administration
Shift First/Day
Full Time / Part Time FULL TIME
Job Description Develop, implement, and oversee activities involved in assuring compliance with the appropriate statutes and regulations and that regulatory reporting
requirements are met with all oncology clinical research within the DCI Oncology CRU.
Responsible for conducting mock audits, identifying educational needs/opportunities for regulatory coordinators and creating training programs, and data and documentation reviews and analysis.
Manage the regulatory coordinators within the oncology, CRU, creating a centralized reporting structurefor thesestaff that are now decentralized.
Work collaboratively with RPM, Monitoring and Safety Managers and all CTMs within the Oncology CRU to insure regulatory compliance.
Ability to multi-task, communicate across all levels of the organization, create a centralized function and form teams that have been decentralized historically.
Highly skilled communicator, ability to present and communicate clearly in written and verbal form.
Minimum Qualifications
Education
Allied Health degree or Associates degree in Clinical Trials Research and 8 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred. OR RN or Bachelor's degree and 6 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred. OR Master's degree and 4 years of related experience, with at least two years in a research setting. ACRP or SOCRA preferred.
Experience
No experience is required beyond what is specified above.
Index Monitor
