Assistant Director, Clinical Research Staff- Winship Cancer Institute

About Winship Cancer Institute of Emory University

Dedicated to discovering cures for cancer and inspiring hope Winship Cancer Institute of Emory University is Georgias only National Cancer Institute-designated Comprehensive Cancer Center a prestigious distinction given to the top tier of cancer centers nationwide for making breakthroughs against cancer. Winship is researching developing teaching and providing novel and highly effective ways to prevent detect diagnose treat and survive cancer. Cancer care at Winship includes leading cancer specialists collaborating across disciplines to tailor treatment plans to each patients needs and type of cancer; innovative therapies and clinical trials; comprehensive patient and family support services; and a personalized care experience aimed at easing the burden of is Where Science Becomes Hope. For more information visit .

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 CRFs 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:

• Masters 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