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Emory Healthcare/Emory University Regulatory Affairs Assistant Director in Atlanta, Georgia

Description

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:

  • high accruals

  • 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

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