Protocol Review Administrator
Job Posting Number: 15233
New York, NY
August 4, 2017
At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes.
For the 27th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2016, as well as Glassdoor’s annual Employees’ Choice Awards 2017. We’re treating cancer, one patient at a time. Join us and make a difference every day.
Improving Time to Activation for research studies is a critical goal for the Center to ensure competitiveness in the industry and also to provide the best available care to MSK patients. As a critical member of the Protocol Activation and HRPP Unit within the Clinical Research Administration and in compliance with all regulatory, institutional, and departmental requirements, the Protocol Review Administrator provides operational, technical, administrative leadership and expertise in protocol review committee management and oversight to over 15 departmental and institutional committees to support the achievement of Center goals for Time to Activation.
- Set and implement standards for protocol review activities, initiates policies and procedures to meet those standards, to ensure the highest quality review of new clinical research studies.
- Anticipate challenges to protocol review and approval and plans effective interventions, based on circumstances.
- Define metrics for determining progress/success, conducts routine and ad hoc analysis of committee outcomes to the physician leadership within clinical departments, institutional committees and members and Center leadership.
- Oversee committee activities to ensure compliance with institutional policies (i.e. Time to Activation, institutional prioritization) and federal requirements and guidelines as required by FDA, OHRP, NIH, CCSG.
- Demonstrate technical expertise in protocol review and the federal/regulatory guidelines as it applies to clinical research at MSKCC.
- Provide timely instruction and guidance to investigators and research staff across the organization on protocol review and approval process, including system support with the Protocol Information Management System (PIMS).
- Bachelor’s degree with at least 7 years of Clinical Research experience, oncology experience strongly preferred with Human Subjects Protection, GCP and GMP standards, FDA/EMA requirements, Quality Standards and Systems experience.
- Experience in staff supervision and management.
- Master’s degree preferred.
- Human Subjects Protection, GCP and GMP standards, FDA/EMA requirements, Quality Standards and Systems experience.
- Demonstrated analytical experience – A strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation (i.e., written, tabular and graphical formats). Excellent problem-solving ability. Ability to analyze situations, draws conclusions, make recommendations and convey information in a timely and proficient manner. Strategic thinker.
- Excellent collaboration and team building skills.
- Ability to drive multiple projects to successful completion -The ability to set priorities among several tasks simultaneously and meet established deadlines. Ability to manage multiple large scale development projects simultaneously. Ability to guide staff to ensure programmatic activities adhere to established time frames and deadlines.
- Demonstrated written communication skills – The ability to develop, facilitate, and orchestrate effective communication with all members of MSK; responsible for the writing, preparing and educating staff on clinical research procedures and processes. Individual must be able to communicate effectively with all levels of staff including clinical staff (investigators, nurses etc), administration, research and clerical support staff, and Institutional Leaders as well as external sponsors. Excellent oral and written communication skills are required.
Experience in a regulated environment – Must have an advanced comprehensive knowledge and understanding of the regulations pertaining to human research protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA).
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
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