Assistant Manager, Clinical Trials- Winship Cancer Institute

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Description

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 Manager, Clinical Trials position. 

KEY RESPONSIBILITIES:

• Responsible for directing and managing large and highly complex clinical research groups.
• With support from operational leadership, assesses team performance, manages distribution of staff workload, and ensures compliance amongst staff.
• Supervises staff to include performance management and development, recruitment, on-boarding.
• May serve as a back-up and fill temporary portfolio management needs.
• Works with clinical research leadership to ensure alignment between team needs and department infrastructure to facilitate strategic planning.
• Provides oversight of the clinical research portfolio, including reviewing potential research opportunities with the Medical Director and Principal Investigators (PI) to evaluate alignment with portfolio development goals, assists in the selection process, and opening of appropriate studies.
• Supports the protocol feasibility review process.
• Tracks team metrics including trial accruals, budget activity, and reports metrics to operational leaders on a regular basis.
• Supports PIs and staff to ensure GCP and institutional compliance for all study protocols.
• Ensures coordinators are adhering to GCP including confirmation of subject eligibility, proper informed consent process & documentation, and protocol adherence.
• Performs quality oversight to include monitoring progress of screening, enrollment, and data submission.
• Ensures compliance with department policies and procedures.
• Identifies barriers to timely study activation, efficient coordination, and identifies/implements potential solutions.
• Ensures timeliness and accuracy of clinical research information and data in all databases and tracking systems.
• Provides support in engaging relevant providers (physicians, advance practice providers, clinic nurses, staff) to ensure that clinical issues at all points of contact, are addressed in a timely and compliant fashion.
• Assists with the development and implementation of departmental specific role-based curriculum for new employees.
• Contributes to the development and refinement of standard operating procedures (SOPs) and assists with SOP training.
• Contributes to the development and execution of educational in-services pertinent to the performance of high-quality clinical research.
• Contributes to the development of study-level corrective action plans, subsequent implementation, and documentation of progress of plans.
• Actively participates in meetings, task forces and committees as assigned.
• Promotes and advances the clinical research activities in a safe, compliant, effective, efficient, and collegial manner.
• Other duties as assigned.

MINIMUM QUALIFICATIONS:

• Bachelor's degree in a scientific, health-related or business administration program required and six (6) years of clinical research experience, with at least four (4) years of Clinical Research Coordinator or Clinical Research Nursing experience,
• OR Master's degree, MD or PhD in a scientific, health related, or business administration program and three years of clinical research experience, OR an equivalent combination of education/experience.
• ACRP/SoCRA (or equivalent) certification required within one (1) year of hire.

NOTE: Position tasks are generally required to be performed in-person at an Emory University location.  Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.

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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 providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to request a reasonable accommodation, please contact the Department of Accessibility Services at 404-727-9877 (V) | 404-712-2049 (TDD). Please note that one week's advance notice is preferred.