The Prostate Cancer Clinical Trials Consortium (PCCTC) is hiring a Clinical Research Project Associate. In this role, you will be responsible for providing support to the Clinical Operations team for multi-center clinical trial activities from concept to close-out.

You will:

• Manage complex multi-institutional clinical trials across a diverse research portfolio.
• Assist in overseeing clinical trials including protocol and informed consent drafting, regulatory document drafting, etc.
• Communicate effectively and establish strong working relationships with a diverse matrix of clinical trial sites, investigators, pharmaceutical & biotechnology partners, and other important stakeholders.
• Sustain project workflows and timelines, ensuring deadlines and milestones are met.
• Maintain comprehensive, GCP/FDA compliant, Trial Master Files for assigned projects. Manage regulatory approvals (ex. IRB), review and filing of documents for Trial Master Files for projects.
• Synthesize complex clinical, regulatory, and other clinical trial information into actionable plans.
• Provide necessary documentation in compliance with existing standard operating procedures, regulatory guidelines, etc.
• Assist in maintaining necessary clinical trial conduct documentation (includes Project Management Plans, Safety Management Plans, Monitoring Plans, Meeting Minutes, etc.).
• Communicate and work effectively with all stakeholders of the PCCTC - Clinical Operations, Data Management, Business Management, Budgets & Contracts, Editorial, etc.

You Are:

• Adept at planning and prioritizing work to meet commitments aligned with organizational goals.
• An effective communicator, capable of determining how best to reach different audiences and executing communications based on that understanding.
• Comfortable working in a fast-paced environment.
• Adept at building partnerships and working collaboratively with others to meet shared objectives and goals.

You Have:

• A Bachelor's degree (preferred) with least 2-4 year of clinical research experience.
• Proven ability to manage clinical research projects with strict deadlines.
• Working knowledge of the Code of Federal Regulations, Good Clinical Practice, and Human Subjects Protection.
• Knowledge of clinical trial regulatory and safety management preferred.
• Strong computing skills including proficiency in MS Office products.
• Ability to solve problems by using a logical, systematic, sequential approach.
• Ability to work productively in a remote work environment.
• Experience working with prostate cancer clinical trials and/or multicenter projects is a plus.

This position is 100% remote.

Benefits

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 Flexibility

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.