Compliance Specialist

The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.

The Alliance for Clinical Trials in Oncology Foundation is seeking a Compliance Specialist who is enthusiastic about supporting and contributing to the development, operations, and activities of the organizational compliance program. This program focuses on the operational aspects of the Alliance, facilitating the conduct of clinical trials and translational research for both academic and community-based studies.

The Compliance Specialist will lead Conflict of Interest (COI) activities for the Alliance and its subsidiaries. While the role is not healthcare-specific, it intersects with healthcare components through collaborations with healthcare professionals and research entities. This position reports to the Senior Director of Organizational Compliance and Human Resources.

BENEFITS:

• 8 weeks of paid time off (including PTO, sick, and holidays) during year one
• Medical, Dental & Vision plans with 100% employer-paid option for employees
• Tuition reimbursement stipends
• Continuing Education
• 3% employer match for retirement investments
• Annual Employee Performance Bonus Program
• Annual Cost of Living Adjustment
• 50% commuter reimbursement
• Healthy Work/Life balance and flexibility

Role & Responsibilities:

• Collaborates with operational departments to ensure compliance with the Alliance and entities Conflict of Interest (COI) policy
• Oversees the collection and assignment of conflict-of-interest disclosure forms from our research enterprise and ensures compliance with required reporting requirements
• Collaborates with the Sr. Regulatory Manager to develop and implement improvements and streamline communications for the Conflict-of-Interest reporting process for Publications
• Assist with risk assessment activities
• Participates in the design and implementation of the annual compliance work plan
• Participates in the delivery of compliance education and training
• Will serve as the primary point of contact for Policy and Standard Operating Procedure (SOP) submissions, review, and approval; tracks and reviews revision dates; ensures departmental Policies and SOPs are current; and maintains oversight of the centralization of these documents
• Keeps current with applicable rules and regulations impacting our organization and industry, including but not limited to FDA, OHRP, GCP/ICH, ORI, Data Protection and Privacy Laws
• Tracks compliance-related metrics
• Works closely and collaborates with the Human Resources department and will interact and collaborate with various departments across the Organization
• Will coordinate and maintain Compliance Oversight Committee meetings and minutes
• Will interact with Senior and Executive Leadership and Investigators throughout the Organization
• Other related duties as assigned to meet departmental and organizational objectives

Qualifications & Educational Requirements:

• A bachelor’s degree in a healthcare-related field is preferred
• Three years or more of relevant work experience in Compliance/Risk Management-related roles in an Academic or healthcare-related environment.
• Prior experience with the conduct of clinical trial research
• Certification in Compliance such as CHRC, CHC, CCEP, a plus

Preferred Skills/Experience:

• Must have strong organizational skills and Proficiency in project Management Proficiency
• Demonstrated ability to work independently and in a team environment
• Proficiency with MS Office Suite (e.g., Word, Excel, PowerPoint, Outlook)
• Excellent oral and written communication skills
• Strong critical thinking and the ability to exercise discretion in reviewing confidential and sensitive information