We have an exciting opportunity for a Research Project Manager (RPM) to join the NCI Network Team.
You will be a member of the Pediatric Brain Tumor Consortium (PBTC) Operations Core, working alongside the National PBTC chair, and NCI leadership to assist with the development and coordination of new clinical research protocols.
You are integrated into MSK and PBTC teams and will coordinate protocol development, submission, and study initiation processes at the National level.
Coordinate the Cancer Therapy Evaluation Program (CTEP) Letter of Intent (LOI) process, develop protocols, and monitor protocol development/initiation submissions timelines.
Develop protocols that are consistent with PBTC templates, standard operating procedures (SOPs) CTEP/NCI regulations and, as appropriate, the Food and Drug Administration (FDA).
Provide updates on the protocol development process to PBTC leadership.
Manage protocols and ensure compliance with PBTC/Federal policies and regulatory requirements. Maintain effective working relationships with PBTC members, scientific leaders in pediatric oncology, and the NCIs protocol development group.
Work as liaison between the study chair, study committee, statisticians, and computing team to identify data to be collected to meet study objectives.
Collaborate on the design of electronic clinical research forms (eCRF) and define the automatic data-driven notifications of the database infrastructure. Manage the protocol and test database prototype prior to study activation.
Draft the Memorandum of Understanding (MOU) defining reimbursement for patient-specific research procedures. Collaborate with the PBTC Operations Officer.
Manage protocols to ensure compliance with Consortium policies and applicable regulatory guidelines.
Ensure timely distribution of CTEP and pediatric Central Institutional Review Board (pedsCIRB) approved protocols to PBTC institutions for local regulatory review.
Facilitate submission of all required documentation for initial and continuing pedsCIRB review of PBTC protocols.
Coordinate and process responses to requests from the IRB of record.
Proven track record to develop clinical research protocols.
Good organizational, prioritization, and project management skills.
Ability to solve problems by using a logical, systematic, sequential approach.
Excellent interpersonal, verbal, and written communication skills.
Attend and participate in semi-annual PBTC meetings.
Bachelors degree with a minimum of 6 years of experience in clinical research or medical writing. Relevant graduate work would be considered in lieu of minimum experience.
Masters degree preferred.
Strong knowledge of word processing, spreadsheet, database and presentation software applications (e.g. Microsoft Word, Excel, Access, PowerPoint)
Knowledge of medical/scientific/technical terminology used in medical research
Must have extensive knowledge and understanding of the regulations pertaining to human subject protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations). Health Insurance Portability and Accountability Act (HIPAA).
Applicants should submit a cover letter addressing qualifications/relevant experience.
Competitive compensation packages | Sick Time |Generous Vacation+ 12 holidays to recharge & refuel| Internal Career Mobility & Performance Consulting | Medical, Dental, Vision, FSA & Dependent Care|403b Retirement Savings Plan Match|Tuition Reimbursement |Parental Leave & Adoption Assistance |Commuter Spending Account |Fitness Discounts &Wellness Program | Resource Networks| Life Insurance & Disability | Remote flexiblity
We believe in communication, openness, and thinking beyond your 8-hour day @ MSK. Its important to us that you have a sense of impact, community, and work/life balance to be and feel your best.
Our Hiring Process
You review the posting, agree it sounds like a great fit & apply ->Talent Acquisition contacts you to schedule a phone interview (if your profile aligns) -> after speaking with the Talent Acquisition Specialist, you will connect with the Hiring Manager by phone or video -> if your experience is a fit, you will move forward to a video call or on-site visit with the team -> post-interview feedback->ideally an offer! ->reference check & onboarding-> orientation & official welcome to MSK.
Internal Number: 2020-43027
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.