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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 Senior Administrator, DSMC. Position details are as follows:

JOB DESCRIPTION:

• The Senior Administrator, Data Safety and Monitoring Committee (DSMC) at Winship supports and coordinates the Data Safety and Monitoring Committees (DSMC) in following the Winship Data Safety and Monitoring Plan (DSMP).
• Responsible for providing quality data in order to respond to the DSMP requirements.
• Provides overall support and organization for all committee functions and responsibilities.
• Serves as a point of contact activities related to monitoring adherence to DSMP and policies and procedures adopted by Winship Cancer Institute as required by the Cancer Center Support Grant Guidelines (CCSG).

The Sr Administrator, DSMC is responsible for:

1. The preparation of the agenda and review of materials prior to the committee meeting to assure that material required for review are available in accordance with the DSMP; and
2. Fulfilling the role of liaison to Committee Chairmen, Program Leaders, Principal Investigators, Regulatory Specialists, and Study Coordinators.

Responsibilities include the following duties:

• Process, review, and assess SAE, device incident, and pregnancy reports from clients' ongoing drug or device clinical trials in a timely manner. Responsible for the maintenance, revision and oversight for the Data Safety and Monitoring Plan (DSMP)
• racking and evaluating monitoring trends for IITs and reporting the trends to Winship CTO Leadership
• Partnering with Training/Education to ensure monitoring trends are addressed within the clinical trials teams and regulatory and training/competency materials are revised to meet compliance standards
•  Ensure compliance with all applicable regulations and timelines for safety case processing and reporting
• Responsible for thorough assessment of required data entry elements and timely accurate input of that data into the Clinical Trials Management System (CTMS) to facilitate efficient project management. This responsibility commences at the original point of project entry, continues through original IRB approval and Activation of the project, and is sustained through periodic monitoring of accuracy and clarity of data elements
• Independently verifies submitted protocols meet requirements for placement on committee agenda by reviewing submitted form, protocol priority diagrams, and protocols prior to assignment.
• Coordinates and attends Data Safety and Monitoring Committee meetings in accordance with Cancer Center Support Grant guidelines to ensure the success of the Cancer Center's protocol review and monitoring process.
• Responsible for compiling agendas, assigning committee reviewers, composing official minutes, and constructing reports and correspondence in final form for Winship review committees, all of which are components essential to the success of the Core Grant
• Prepares DSMC documents in collaboration with the study PI, including confidentiality agreements, conflict of interest statements and charters for each study requiring DSMC review
• Disseminates policy decisions and resolutions to Winship study teams from the Data Safety and Monitoring Committees
• Takes on special projects or tasks as required and needed.
• Ensures orientation and training policies for investigators comply with local and federal regulations and accreditation standards.
• Seek out new practice methods and principles, applying them to existing clinical research practices.
• Assists the program and offices in complying with all accreditations, legal, regulatory, and safety requirements
• Uses group participation skills when working as a member of a committee or informal work group. Participates actively and positively on assigned committees. Accurately identifies opportunities for improvement. 
• Actively demonstrate facilitative leadership to foster productive teamwork through coaching, mentoring, and couseling.
• Other duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

MINIMUM QUALIFICATIONS:

• Bachelor's degree in a related field (scientific or health related) and seven years of experience in clinical trials management, sponsored research, or regulatory management, including five years trial or related monitoring experience
• OR an equivalent combination of education and experience. Certification by Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ASCP) is required within three (3) years of hire.

PREFERRED QUALIFICATIONS:

• Previous supervisory experience.
• Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
• Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
• Experience with good clinical practices and clinical trials development or implementation. Familiarity with Clinical Trials Monitoring Systems (CTMS).
• Experience as a clinical manager, operations manager, or general manager.
• Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards.
• Experience in indirect management of team members, including assisting in the development, training, and assignment of work/projects to other team members.

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 Senior Administrator, DSMC. Position details are as follows:

JOB DESCRIPTION:

• The Senior Administrator, Data Safety and Monitoring Committee (DSMC) at Winship supports and coordinates the Data Safety and Monitoring Committees (DSMC) in following the Winship Data Safety and Monitoring Plan (DSMP).
• Responsible for providing quality data in order to respond to the DSMP requirements.
• Provides overall support and organization for all committee functions and responsibilities.
• Serves as a point of contact activities related to monitoring adherence to DSMP and policies and procedures adopted by Winship Cancer Institute as required by the Cancer Center Support Grant Guidelines (CCSG).

The Sr Administrator, DSMC is responsible for:

1. The preparation of the agenda and review of materials prior to the committee meeting to assure that material required for review are available in accordance with the DSMP; and
2. Fulfilling the role of liaison to Committee Chairmen, Program Leaders, Principal Investigators, Regulatory Specialists, and Study Coordinators.

Responsibilities include the following duties:

• Process, review, and assess SAE, device incident, and pregnancy reports from clients' ongoing drug or device clinical trials in a timely manner. Responsible for the maintenance, revision and oversight for the Data Safety and Monitoring Plan (DSMP)
• racking and evaluating monitoring trends for IITs and reporting the trends to Winship CTO Leadership
• Partnering with Training/Education to ensure monitoring trends are addressed within the clinical trials teams and regulatory and training/competency materials are revised to meet compliance standards
•  Ensure compliance with all applicable regulations and timelines for safety case processing and reporting
• Responsible for thorough assessment of required data entry elements and timely accurate input of that data into the Clinical Trials Management System (CTMS) to facilitate efficient project management. This responsibility commences at the original point of project entry, continues through original IRB approval and Activation of the project, and is sustained through periodic monitoring of accuracy and clarity of data elements
• Independently verifies submitted protocols meet requirements for placement on committee agenda by reviewing submitted form, protocol priority diagrams, and protocols prior to assignment.
• Coordinates and attends Data Safety and Monitoring Committee meetings in accordance with Cancer Center Support Grant guidelines to ensure the success of the Cancer Center's protocol review and monitoring process.
• Responsible for compiling agendas, assigning committee reviewers, composing official minutes, and constructing reports and correspondence in final form for Winship review committees, all of which are components essential to the success of the Core Grant
• Prepares DSMC documents in collaboration with the study PI, including confidentiality agreements, conflict of interest statements and charters for each study requiring DSMC review
• Disseminates policy decisions and resolutions to Winship study teams from the Data Safety and Monitoring Committees
• Takes on special projects or tasks as required and needed.
• Ensures orientation and training policies for investigators comply with local and federal regulations and accreditation standards.
• Seek out new practice methods and principles, applying them to existing clinical research practices.
• Assists the program and offices in complying with all accreditations, legal, regulatory, and safety requirements
• Uses group participation skills when working as a member of a committee or informal work group. Participates actively and positively on assigned committees. Accurately identifies opportunities for improvement. 
• Actively demonstrate facilitative leadership to foster productive teamwork through coaching, mentoring, and couseling.
• Other duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

MINIMUM QUALIFICATIONS:

• Bachelor's degree in a related field (scientific or health related) and seven years of experience in clinical trials management, sponsored research, or regulatory management, including five years trial or related monitoring experience
• OR an equivalent combination of education and experience. Certification by Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ASCP) is required within three (3) years of hire.

PREFERRED QUALIFICATIONS:

• Previous supervisory experience.
• Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
• Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
• Experience with good clinical practices and clinical trials development or implementation. Familiarity with Clinical Trials Monitoring Systems (CTMS).
• Experience as a clinical manager, operations manager, or general manager.
• Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards.
• Experience in indirect management of team members, including assisting in the development, training, and assignment of work/projects to other team members.

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.