Regulatory Affairs Manager Jobs

Our client is in search of a Quality and Regulatory Manager, to oversee the IRB & Regulatory Specialist staff who work integrally with internal research teams and serves an Institutional Review Board (IRB) and regulatory subject-matter resource.

The Manager acts as a liaison between internal, industry sponsors and the various IRBs that our client partners with, secures IRB approval for new research studies, and ensures effective and timely reporting and exchange of regulatory correspondence and metrics related to the multitude of research studies performed.

Dependent upon interest, experience, and need, the Manager may also have growth/development opportunities such as oversight of quality monitoring or contributing to research education and training.

Essential Functions:

INDIVIDUAL CONTRIBUTOR RESPONSIBILITIES

• Serves as an expert resource to research study staff and investigators in the interpretation and application of IRB requirements, the Health Insurance Portability and Accountability Act (HIPAA), Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines and CLIENT Standard Operating Procedures (SOPs).
• Communicates regularly with research study staff, sponsors, IRBs and other stakeholders regarding the status of startup and ongoing regulatory duties.
• Provides regulatory assistance to the research teams by collecting, preparing, editing and submitting IRB applications, consent forms, regulatory documentation, reports and correspondence.
• Works collaboratively with leadership and employees as part of a positive, supportive culture.
• Updates and maintains a study database with essential information on all studies.

MANAGER/OVERSIGHT RESPONSIBILITIES

• Assists in monitoring and auditing selected research projects on an as needed basis to ensure compliance with applicable internal, federal and state regulations.
• Provides VP with routine metrics, analysis and reporting related to regulatory and compliance functions and works collaboratively on potential solutions to address concerns or areas of potential risk.
• Leads efforts to assess potential expansion of regulatory staff role and assists in development, change management around and implementation of any expansion.
• Provides leadership and supervision to the IRB & Regulatory Specialists, including coaching, performance management and staff development.
• With department VP, develops, contributes to and supports functional area strategic planning and continuous process improvement activities to align with internal goals.
• May participate in Emerging Leaders opportunities as available and appropriate.
• Creates and improves upon SOPS, guidelines, tools, and processes to support high-quality IRB and regulatory work and general research compliance. Partners with Research Operations, Scientific Services and others in the development and maintenance of operational SOPs.
• Delivers routine educational and training content to research staff on an as-needed basis.
• Scans, evaluates and translate for implementation changes in applicable laws, regulations, guidance, Federal agency expectations and national practice standards.

ADDITIONAL OPPORTUNITIES

• With VP, develops and implements robust, multi-faceted internal quality monitoring program, to include creation of tools, strategic plan and routine metrics and reporting.
• Other opportunities for significant, high-level contribution may be available dependent upon candidate interest and experience and program need.
• Develops, oversees and delivers robust initial and continuing training and education for investigators and staff on matters such as regulatory compliance, HIPAA, GCP guidelines, and inspection-readiness. Participates in new research staff onboarding and competency standard development and maintenance.

Relationships:

This position reports to the VP, Compliance, Quality and Regulatory. The incumbent consults with the Vice President of Research Operations and Director of Scientific Services on the prioritization of new study submissions and associated timelines. The Manager works closely with CLIENT research managers, staff, internal and external IRBs and key Allina Health stakeholders and partners.

Qualifications:

Required:

• Bachelor’s degree
• Working knowledge of applicable FDA, IRB and HIPAA regulations and guidance, ICH GCP standards, etc.
• Recognizes problems or situations that are new or do not have clear precedent; evaluates alternatives and finds solutions that fall within applicable policies and regulations
• Strong interpersonal and influence skills with the ability to work with others as a team and in support of a positive work culture across enterprise and cross-functional
• Ability to think critically, exercise sound independent judgment, adapt to an evolving internal and external regulatory environment, and manage competing priorities
• Demonstrated readiness to assume a leadership role (e.g. had direct supervisory experience or provided direction to other staff, assumed interim leadership role, led individual projects, etc.)
• Proficiency using technology to support routine office and specialized research functionality
• 5 years of experience in research with a deep understanding of the clinical research and IRB oversight processes

Preferred:

• Cardiovascular research experience or general knowledge of common cardiovascular medical terminology
• Certification in clinical research, IRB, or healthcare compliance (including but not limited to CCRA, CCRC, ACRP-CP, or CIP)
• Experience developing and delivering educational content
• Experience auditing or monitoring research
• Previous supervisory or other leadership experience