Assistant Director, Clinical Research Staff- Winship Cancer Institute

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About Winship Cancer Institute of Emory University

Dedicated to discovering cures for cancer and inspiring hope, Winship Cancer Institute of Emory University is Georgia’s 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 patient’s 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 cancer. Winship is Where Science Becomes Hope®. For more information, visit winshipcancer.emory.edu.

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

Additional Details

Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD).

Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call 404-727-9877 (Voice) | 404-712-2049 (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.

About Winship Cancer Institute of Emory University

Dedicated to discovering cures for cancer and inspiring hope, Winship Cancer Institute of Emory University is Georgia’s 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 patient’s 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 cancer. Winship is Where Science Becomes Hope®. For more information, visit winshipcancer.emory.edu.

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

Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD).

Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call 404-727-9877 (Voice) | 404-712-2049 (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.