Details
Posted: 07-Aug-22
Location: New York, New York
Salary: Open
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
Our growing Protocol Activation Team has an exciting opportunity for a Manager, Study Start-Up. You will lead the activation of clinical research studies, coordinating with other Clinical Research Administration teams to ensure that the Center's goals for Time to Activation are met. Join us today and help make a difference every day!
You Will:
- Direct and lead protocol activation for assigned protocols ensuring customer focus, activation goals and accountability.
- Collaborate and communicate effectively with all internal and external stakeholders
- Assess complex protocols quickly to plan an effective activation pathway and manage all submissions to departmental/scientific review committees, sponsors, and IRB to meet time to activation expectations while ensuring high quality.
- Ensure that all protocol documents are clear and follow Federal Regulations and Institutional policies
- Writes informed consent forms and other patient facing protocol documents and negotiates documents with external industrial sponsors as necessary
- Ensure Principal Investigators and Clinical Research Managers (and others as needed) are notified of protocol status throughout the entire process through metrics, dashboards, and reporting.
- Evaluate internal protocol activation requirements to determine when a protocol can be opened to patient/participant accrual
You Have:
- 4-7 years of clinical research experience.
- Experience with Human Subjects Protection, GCP and GMP standards, FDA/EMA requirements, Quality Standards and Systems.
- Experience working with sponsors and protocol development.
Hours:
- Monday - Friday, 9 AM - 5 PM. This role is hybrid, which means that the individual will be required to come on site up to 2 times per month.
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!
#LI-POST
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.