Details
Posted: 19-Jun-22
Location: New York, New York
Salary: Open
Categories:
Academic / Research
Company Overview
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. We're treating cancer, one patient at a time. Join us and make a difference every day.
In compliance with applicable New York and New Jersey State regulatory authorities, COVID-19 vaccination (2 doses of either the Pfizer or Moderna vaccine or one dose of the Johnson & Johnson vaccine) is mandatory for all MSK employees, contingent workers, and volunteers. Exceptions are permitted for those employees who request and receive an approved medical or fully remote exemption.
*Staff working at a MSK New Jersey location must be up to date with COVID-19 vaccination, which includes having completed the primary COVID-19 vaccination series and booster once eligible as mandated by New Jersey State. All New Jersey staff not yet eligible for a booster must receive a booster within 3 weeks of becoming eligible as a condition of continued employment at MSK.
Note: Individuals are eligible to receive a COVID-19 booster five months after receiving the second dose of either the Pfizer or Moderna vaccine or two months after the J&J vaccine.
Job Description
The Human Research Protection Program (HRPP) is seeking an experienced and innovative Project Manager to manage the IRB of record (IoR) responsibilities within the HRPP Operations Office. An IoR is the IRB responsible for the review and oversight of human subjects' research. Federal regulations and institutional initiatives require MSK IRBs to serve as the IoR for outside sites participating in a research study and for some research studies to cede IRB review to an outside entity. Join us today and help make a difference every day!
You are:
- A strong project manager with the ability to create project plans and communicate with various internal and external stakeholders.
- An excellent communicator that will be able to explain, interpret, share and present information on IRB of Record related projects to investigators, staff, and appropriate external contacts.
- Excellent at time management, especially when involved with simultaneous management of multiple projects.
You will:
- Serve as a liaison to investigators and research staff for human subjects protections and regulatory compliance providing guidance and troubleshooting issues.
- Review reliance agreements and local context forms to ensure they meet MSK standards.
- Work with outside entities as central contact for IoR correspondence.
- Keep informed of new and changing IoR regulation and adjust workflows and policies as needed.
- Create and upkeep HRPP Office templates and Clinical Research Portal pages as related to IoR items.
- Have in-depth knowledge of the processes/procedures associated with clinical research.
- Maintain, develop and implement methods and tools by which to organize, standardize and manage project activities.
You need:
- Knowledge of State and Federal HHS regulations regarding human subjects protection (45 CFR 46), the HIPAA Privacy Rule (45CFR 160,164), the FDA (21 CFR 50, 21 CFR 56).
- Experience with database management.
- Ability to solve problems by using a logical, systematic, sequential approach.
- Excellent interpersonal, verbal and written communication skills.
- Strong organizational, prioritization, and project management skills.
We believe in communication, openness, and thinking beyond your 8-hour day @ MSK. It's important to us that you have a sense of impact, community, and work/life balance to be and feel your best!
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Closing
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.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.