Emory Healthcare/Emory University Regulatory Affairs Assistant Director in Atlanta, Georgia
Participates in the strategic planning, development and implementation of the compliance and monitoring program. Responsibilities include:
Assists in providing Winship specific education and training. Responsible for the management of all Regulatory and Compliance staff.
Responsible for assuring that Emory Winship Clinical Trials are compliant with regulations.
Hires, trains, and evaluates staff. Develops and adheres to a clinical trials monitoring plan consistent with the Winship Cancer Institute Data Safety Monitoring Plan, including investigator-initiated studies.
Creates a monitoring plan that includes the anticipation of and the preparation for FDA audits for studies with:
significant (in number or severity) protocol deviations/violations/adverse events/SAEs/unanticipated problems involving risk to participants or others, and
high visibility nationally or with NCI.
Reviews results of industry site monitoring visits and identify who will respond and monitors the timeliness of response to all immediate action items.
Incorporates the use of ONCORE (and/or other approved Winship or CTO electronic technologies) in the daily operations.
Integrates processes to ensure study data is updated in a timely manner.
Holds staff accountable for timeliness and accuracy of updates to the system(s).
Provides education to the Winship community and CTO personnel in all aspects of clinical trials compliance.
Helps to develops Winship specific minimum learning standards/requirements for regulatory and monitoring personnel and physician-investigators, and maintains appropriate training records for participants.
Develops tracking and adheres to performance measures for study submissions including new, continuing reviews & amendments.
Develops an integrated, Winship specific orientation and maintains appropriate training records for participants.
Communicates and models mission and values of Winship Cancer Institute.
Trains, models and promotes the principals for effective customer service.
Identifies, establishes and evaluates quality improvement standards, programs and procedures within the group and Winship Cancer Institute.
Provides leadership in process improvement projects. In collaboration with the Winship Data Safety Monitoring Committee chairperson, coordinates the Winship Data Safety Monitoring Committee.
Promotes professional self-development by attending seminars, reading professional publications and taking part in professional organizations.
Assists principal investigators as appropriate with the organization's protocol review process. Responsible for regulatory compliance at all levels.
Responsible for Performance Improvement and Quality Improvement activities within Winship Clinical Trials and collaborates with others within Winship, Emory and Emory Healthcare to identify, establish and evaluate quality measures.
Performs additional responsibilities as required.
MINIMUM QUALIFICATIONS: Bachelors Degree. Five years of leadership experience in research field. Certification in one or more related specialty (CPI, ACRP, SOCRA, etc.) preferred.
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Job Number 40818
Job Type Regular Full-Time
Division Exec.V.P. for Health Affairs
Department Winship Clinical Trials
This position may involve the following Health and Safety issues: Not Applicable
Job Category Research & Research Administration
Location : Name Emory Campus-Clifton Corridor
Emory Healthcare/Emory University
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