Emory University

Assistant Director, Clinical Research Staff- Winship Cancer Institute

Emory University • $90K — $120K *
Atlanta, GA 30349In-Person
Healthcare
5 - 7 years of experience
More than 3 months ago
Job Overview by Ladders

Qualifications

  • Master's degree in a health-related field or Business Administration
  • 5 years of relevant experience with supervisory roles
  • Experience in clinical trials or nursing
  • Strong knowledge of regulatory requirements (FDA, GCP, ICH)
  • Certifications like SOCRA/ACRP preferred

Responsibilities

  • Supervise clinical research staff and ensure effective training
  • Oversee hiring, training, and performance evaluations of team members
  • Manage timely financial reporting for staff efforts
  • Develop, implement, and maintain SOPs for adverse event reporting
  • Monitor and ensure sponsor queries are addressed promptly
  • Implement strategies for timely completion of clinical reporting forms (CRFs)
  • Educate staff and facilitate development of patient resources for clinical trials

Benefits

  • Opportunity to work in a leading cancer research center
  • Engagement in continuous staff education and professional development
  • Strong collaboration with a well-respected healthcare institution
  • Focus on regulatory compliance and adherence to high standards
  • Possibility of developing industry-specific knowledge and networks
Full Job Description
Description

Winship is seeking qualified candidates for the Assistant Director, Clinical Research position. Position details are as follows:

JOB DESCRIPTION:
  • Provides direct supervision of staff; prepares operational reports and assists in providing Winship specific education and training.
  • Responsible for direct oversight and supervision of Clinical Research Nurses, Clinical Research Coordinators, Assistant Managers, and Clinical Research Operations Managers. (Clinical Research Staff).
  • Hires, trains, and evaluates staff.
  • Tracks and assures timely management of staff effort reporting for financial management.
  • Assists the director in the understanding and applying the business model as needed.
  • Reviews site monitoring visit outcome letters and responds to all exit reviews.
  • Develops, implements and maintains SOPs to ensure timely reporting of adverse events, serious adverse events and unanticipated problems to the Winship Data Safety Monitoring Committee.
  • Monitors the timeliness of response to all sponsors request for queries by working groups.
  • Develops strategies to maximize timely completion of CRF's within the program. Incorporates the use of ONCORE in daily operations.
  • Integrates processes to ensure subject data in Oncore is updated in a timely manner. Holds staff accountable for timely and accurate data updates.
  • Provides education to the Winship community and Emory personnel in all aspects of clinical trials.
  • Helps develop Winship specific minimum learning standards/requirements for Clinical Coordinators and physician-investigators.
  • Works with clinical staff in developing and implementing patient education resources for clinical trials.
  • Collaborates with Emory Healthcare Nursing and Office of Quality in developing protocol specific materials for the orientation and education of clinical staff in the conduct of clinical research protocols.
  • Demonstrates knowledge of and competency in all regulatory requirements (FDA, GCP, ICH). Responsible for regulatory compliance at all levels.
  • Performs other responsibilities as required.
  • Foster strong sponsor relationships through regular engagement, proactive issue resolution, and effective escalation management.
  • Maintain strong relationships with investigators through consistent touchpoints, proactive escalation management, assistance with portfolio review and alignment and targeted education on Emory and Winship procedures and and resources.

MINIMUM QUALIFICATIONS:
  • Master's degree in a health related discipline or Business Administration and five years of progressively responsible research, nursing, clinical trials or related experience which includes supervisory responsibility
  • OR an equivalent combination of education, training and experience.

PREFERRED QUALIFICATION:
  • SOCRA/ACRP or related research certification

About Emory University

Emory University is a private research university in Atlanta, Georgia. The university was founded in 1836 as Emory College and has since grown into a leading research institution with nine academic divisions. Emory University is known for its liberal arts college, professional schools, and biomedical research. The university has a diverse student body and offers undergraduate, graduate, and professional degree programs. Emory University is consistently ranked among the top 25 universities in the United States and is a member of the Association of American Universities.
Learn more about Emory University
Size
30,000 employees
Industry
Education, Government & Non-Profit
* Ladders Estimates

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