Are you interested in playing a key role in integrating optimal protocol activation functioning for clinical research?
At MSK, were running one of the largest clinical trials programs for cancer in the country, and at any time we are conducting hundreds of clinical trials to improve cancer care. Our Protocol Activation Core was created in January 2018. We are a centralized team handling protocol activation for all clinical trials at MSK. We are seeking a Protocol Activation Manager to join our dynamic team. In this role, you will lead the activation of assigned clinical research studies and coordinate all aspects of protocol activation.
Direct and lead all protocol activation for assigned protocols ensuring customer focus, activation goals and accountability
Manage complexity and obtain clear understanding about protocol hypothesis, scientific background, research rationale, participant work flow, potential side effects, risks and benefits, costs, etc to ensure optimal activation strategy and appropriate reviews.
Collaborate and communicate effectively with all internal and external stakeholders on assigned protocol areas to have a complete and full understanding of the protocol and ensure rapid activation.
Assess complex protocols quickly to plan an effective activation path and manage all submissions to review committees, sponsors, CRA units and clinical departments per institutional guidelines to meet time to activation expectations while ensuring high quality.
Ensure that all protocol documents are clear and follow Federal Regulations and Institutional policies.
Advise, assist, and guide Principal Investigators in appropriate responses to sponsors, review committees, and units.
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.
Track protocols as they move through the review process, involving necessary staff and Leadership as required.
Ensure all required reviews, approvals, budgets, contracts, logistic and feasibility reviews, site initiation visits, order sets/CTMS calendars and drug/device are in place (if applicable) and all regulatory and institutional activation steps have occurred.
Determine when a protocol can be opened to patient/participant accrual.
Write informed consent document and convert model consents to MSK template.
Negotiate consent language with external Industrial sponsors, ensuring that sponsor(s) understand expectations of MSKCCs IRB and utilization of MSK standard text.
Able to interpret complex research protocols quickly and discern the explicit and implicit items needed for activation.
Able to navigate and champion protocols through a complex system involving various internal and external departments involved in human research studies.
Able to hold yourself and others accountable in order to achieve goals and live up to commitments.
Focused on continuous improvement, knowing the most effective and efficient processes to optimize work flow.
Flexible in your approach and demeanor in order to align with the shifting demands of evolving circumstances.
A Bachelor's degree (preferred), with 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
Experience with protocol development #LI-POST
Internal Number: 2020-42333
About Memorial Sloan-Kettering Cancer Center
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.