Compliance Specialist

1 month ago

Chicago, United States Alliance for Clinical Trials in Oncology Full time

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 looking for a Sr. Compliance Coordinator who is excited to help pioneer our newly established corporate compliance department. In this exciting role, you will have hands-on participation in drafting and implementing policies and procedures, which includes an educational component. You will also be involved with conflict of interest, risk management, monitoring, and auditing activities. We are an organization of passionate, team-oriented professionals driven to change the face of cancer.

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:

  • Assists in drafting programmatic and organizational policies and standard operating procedures
  • Participates in the design and implementation of the annual compliance work plan
  • Participates in the development and delivery of compliance education and training
  • Assist with risk assessment activities
  • Collaborates with the operational departments to ensure compliance with the Alliance Conflict of Interest (COI) policy.
  • Oversees the collection and evaluation of conflict-of-interest forms from Alliance investigators and ensures compliance with NIH reporting requirements 
  • Serves as the primary point of contact for Policy and Standard Operating Procedure (SOP) submissions for review, tracks and reviews revision dates, and ensures departmental Policies and SOPs are current; and maintains a centralized library for these documents
  • Coordinates and maintains Compliance Oversight Committee meetings and minutes
  • Investigates, researches, and responds to compliance questions and concerns
  • Keeps current with applicable rules and regulations impacting our organization and industry
  • Develop compliance-related reports/metrics
  • Works closely and collaborates with the Human Resources department and will interact and collaborate with a variety of departments across the Organization
  • Will interact with Senior and Executive Leadership and Investigators throughout the Organization
  • Other related duties as assigned to meet departmental and Organizational objectives

Requirements:

  • Bachelor's degree in a Healthcare related field from an accredited university
  • Three years or greater of relevant work experience in Compliance/Risk Management-related roles in the healthcare industry, such as an Academic Medical Center
  • Demonstrated working knowledge of Good Clinical Practice (GCP), and FDA Code of Federal Regulations on 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

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