Compliance Specialist

3 weeks ago

Chicago Illinois, United States Alliance for Clinical Trial in Oncology Foundation 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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