Abilitylab Compliance Manager

By joining our team, you'll be part of our life-changing Mission and Vision. You'll work in a truly inclusive environment where diversity and equity are championed through words and actions. You'll contribute to an innovative culture that is second to none, one that embraces curiosity, discovery and compassion. You'll play a role in something that's never been done before as we integrate science and clinical care to help patients achieve better, faster outcomes - as we Advance Human Ability, together.

Job Description Summary

The AbilityLab Compliance Manager will work across all labs at Shirley Ryan AbilityLab Research Program. This role will work in collaboration and consultation with the Corporate Compliance Program, to ensure all research activities comply with federal, state, and institutional regulations including those used for clinical trials. This role is responsible for providing training and operational support to enhance the conduct of human subject research at Shirley Ryan AbilityLab. The Manager will additionally provide oversight and support to ensure clinical research performed at SRAlab is conducted in accordance with research requirements, applicable policy and best practices.

The AbilityLab Compliance Manager will assist Principal Investigators and their teams submit all appropriate documents (i.e., original requests, modifications, etc.) to all IRBs, including the Northwestern IRB. This role will maintain "best practices" related to all documentation as well as policies and practices related to study files and access, regulatory documentation, processes to manage ongoing compliance needs, training and education related to institutional and best practices, as well as manage compliance issues to support ethical and compliant research practices. This role requires strong prioritization, interpersonal skills, operational savvy and adaptability to meet the varying needs of diverse Principal Investigators and their teams. In addition, it requires strong communication skills to ensure engagement at all levels within the Research labs as well as Compliance and to ensure an environment of transparency and continual improvement.

The AbilityLab Compliance Manager will consistently be a role model for compliant behavior and demonstrate support of the SRAlab statement of Vision, Mission and Core Values by striving for excellence, contributing to the team efforts and showing respect and compassion for patients and their families, fellow employees, and all others.

The AbilityLab Compliance Manager will demonstrate SRAlab Core Attributes: Communication, Accountability, Flexibility/Adaptability, Judgment/Problem Solving, Customer Service and SRAlab Values (Hope, Compassion, Discovery, Collaboration, and Commitment to Excellence) while fulfilling job duties.

Job Description

The AbilityLab Compliance Manager will:

• Ensure Appropriate Documentation at Grant Inception: Ensure from the inception of any new grant or research project that systems are in place to ensure appropriate documentation, access and "best practices" related to all studies.

• Identify and Implement Best Practices and Gaps: Be responsible for identifying "best practices" and gaps in existing human clinical research practices at all labs at SRAlab and develop and implement new procedures to address identified gaps.

• Coordinate IRB communications: Facilitate communication with all IRBs, including the Northwestern IRB, and study staff including routine communications, scheduling, and comments provided via the electronic IRB platform. In addition, collaborates with Shirley Ryan AbilityLab's Corporate Compliance Program, when any issues arise related to the IRB.

• Develop and Implement Policies and Procedures: Create and implement appropriate policies and procedures for research activities to ensure compliance across all labs in the Research Department. Partner with the SRAlab Corporate Compliance and Office of General Counsel on interpretation of research related requirements and relevant policy and assist in communication thereof.

• Submit initial documentation as well as any subsequent submissions: Ensure all initial documentation as well as any subsequent submissions (i.e., amendments and modifications) meet compliance standards and are consistent with lab practices.

• Provide Guidance, Education and Training: Educates PIs and study teams on regulatory policy, IRB requirements and best practices to ensure accuracy, compliance, and efficiencies. Develop an education and training program for all labs on compliance-related issues in conjunction with the Corporate Compliance Program and Office of General Counsel. Provides guidance to researchers on practices related to maintenance of study documentation, record retention and current and completed studies are catalogued and archived appropriately, along with other questions and issues that arise.

• Maintain Knowledge of Regulations: Stay updated on laws, regulations, and ethical standards in human subjects research, clinical trials, and general research practices as well as evolving "best practices."

• Prepare Regulatory Binders and Ad Hoc Audit Support Materials in Conjunction with Lab staff: Compile, in conjunction with Lab staff, regulatory binders and additional supporting documentations for review by regulatory bodies during all audits (i.e., internal, external, routine, for-cause audits).

• Manage Research Data: Ensure the integrity and security of research data.

• Perform all other duties that may be assigned in the best interest of SRAlab.

Reporting Relationship

• Reports directly to the Senior Vice President, Chief Scientific Officer with an indirect reporting relationship with Corporate Compliance Officer.

Knowledge, Skills & Abilities Required

• Education: Bachelor's degree in a related field (e.g., Life Sciences, Law, Ethics).

• Experience: Minimum of three (3) to five (5) years of experience in research compliance or a related field.

• Skills: Strong knowledge of research regulatory and IRB requirements, as well as excellent analytical and problem-solving skills, especially in an academic medical center environment.

• Demonstrated experience with project planning and training in a complex, regulated environment.

• Communication and interpersonal skills necessary to interact on a daily basis with scientists, IRB members, administrators, and other regulatory personnel.

• Advanced organizational skills necessary to efficiently prioritize and complete a variety of tasks and provide leadership when required.

• Ability to collaborate effectively in a team setting in order to maximize quality and efficiency of operations.

• Certifications: Relevant certifications (e.g., Certified IRB Professional) are a plus.

Working Conditions

• Normal office environment with little or no exposure to dust or extreme temperature.

Pay and Benefits*:

Pay Range: $71,278.00 annually - $124,500.00 annually

Benefits: Shirley Ryan AbilityLab offers a comprehensive benefits program that is competitive with our industry peers in our geographic locations: https://www.sralab.org/benefits

• Benefits and benefits' eligibility can vary by position. Actual compensation will vary based on applicant's experience and qualifications, as well as internal equity.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

Equal Employment Opportunity

ShirleyRyan AbilityLab is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.