The Director of Regulatory and Compliance reports to the CEO/Executive Director and ensures that the Altitude Regulatory Department is optimized to reach regulatory milestones and goals.
Essential Duties & Responsibilities
In collaboration with the senior leadership at Western States Cancer Research NCORP, d.b.a. Altitude Clinical Research, the Director of Regulatory and Compliance will act as relationship manager between WSCR consortium sites, potential partners/affiliates, physician and non-physician investigators, and research staff and study sponsors. S/he will ensure Altitude research project goals and objectives are met, assure projects are managed within the defined scope of work and that project deliverables and timelines are met. S/he will provide expert regulatory guidance and help resolve complex system and operational matters to ensure compliance with all applicable policies, procedures, and regulations. S/he will foster a collaborative team culture while ensuring clinical trial goals and timelines are met with quality, in compliance with SOPs and regulatory guidelines.
Key functions:
- Provide input to strategic decisions that affect the functional areas of Altitude research programs
- Collaborate with cross functional teams to provide functional support to clinical study projects
- Participate in Altitude leadership conferences, meetings, and strategic planning at the discretion of executive leaders
- Ensure timely and effective communication and updates to both internal and external stakeholders including NCTN Member Institutions, NCORPs/LAPs, Principle and Sub-Investigators, industry collaborators and others.
- Have adequate knowledge and perspective of Altitude research and business operations
- Quickly identify and troubleshoot obstacles and escalate issues to management as necessary
- Responsible for combining clinical operations and technology skills with strong leadership, communication, negotiation, facilitation, and presentation skills
- Responsible for reviewing and verifying the alignment between protocol, study events, and financial outcomes within the CTMS application
- Provide adequate training of CTMS system functionality to study teams, including external partners, sponsor and/or site staff, to ensure that study teams have the guidance needed to work CTMS features independently; check-in periodically with study teams to offer ongoing support
- Monitor all study-related communication and protocol amendments to identify opportunities for process improvement in how study-related communications are drafted and disseminated
- Ensure all trial-related activities must be carried out in accordance with WSCR and NCI Standard Operating Procedures (SOPs) and the relevant Federal, State and Good Clinical Practices (GCP) regulations
REQUIRED EDUCATION AND/OR EXPERIENCE:
- Minimum of two years’ experience in database management or management of Clinical Trials Management Systems (CTMS)
- Strong computer skills
- Minimum of five years’ NCORP experience to include study management and oversight of program operations
- Knowledgeable about oncology clinical research and clinical trials
- Bachelor’s degree, Master’s preferred
- Working knowledge of oncology clinical trial operations, protocol start-up and management, NCI NCTN specifically NCORP.
- Knowledge of and practice with federal, state, and local regulations governing protection of human subjects and conduct of research.
Job Type: Full-time
Pay: $85,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Education:
Work Location: In person
