Assistant Director, Clinical Research Staff- Winship Cancer Institute

Emory University•Brookhaven, GA

About The Position

Winship is seeking qualified candidates for the Assistant Director, Clinical Research position. This role provides direct supervision of staff; prepares operational reports and assists in providing Winship specific education and training. The Assistant Director is responsible for direct oversight and supervision of Clinical Research Nurses, Clinical Research Coordinators, Assistant Managers, and Clinical Research Operations Managers. This role involves hiring, training, and evaluating staff, and tracking and assuring timely management of staff effort reporting for financial management. The Assistant Director will assist the director in understanding and applying the business model as needed, review site monitoring visit outcome letters, and respond to all exit reviews. Key responsibilities include developing, implementing, and maintaining SOPs to ensure timely reporting of adverse events, serious adverse events, and unanticipated problems to the Winship Data Safety Monitoring Committee. The role also monitors the timeliness of response to all sponsor requests for queries by working groups, develops strategies to maximize timely completion of CRFs within the program, and incorporates the use of ONCORE in daily operations. This includes integrating processes to ensure subject data in Oncore is updated in a timely manner and holding staff accountable for timely and accurate data updates. The Assistant Director will provide education to the Winship community and Emory personnel in all aspects of clinical trials, help develop Winship specific minimum learning standards/requirements for Clinical Coordinators and physician-investigators, and work with clinical staff in developing and implementing patient education resources for clinical trials. Collaboration with Emory Healthcare Nursing and the Office of Quality is expected in developing protocol specific materials for the orientation and education of clinical staff. The role requires demonstrated knowledge of and competency in all regulatory requirements (FDA, GCP, ICH) and is responsible for regulatory compliance at all levels. Additionally, the Assistant Director will foster strong sponsor relationships through regular engagement, proactive issue resolution, and effective escalation management, and 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 resources. Performs other responsibilities as required.

Requirements

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.

Nice To Haves

SOCRA/ACRP or related research certification

Responsibilities

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.
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.