For more than 32 years, Sterling IRB has helped lead the way in safeguarding the rights and welfare of clinical research participants. Located in Atlanta, Georgia, Sterling is currently seeking a knowledgeable and dedicated professional to serve as Director of Regulatory Compliance and Quality Management.
The Director of Regulatory Compliance & Quality Management is responsible for the development and oversight of all regulatory, compliance, quality assurance, and educational components of the IRB. This role requires expertise in the Common Rule (45CFR46), Food and Drug Administration (FDA) regulations, International Council on Harmonization (ICH) Good Clinical Practice Guidelines, and other relevant requirements and guidelines related to the ethical study of human research subjects.
The primary responsibilities of the Director of Regulatory Compliance and Quality Management include:
- Develop, implement, and manage the organization’s compliance program.
- Monitor and evaluate regulatory and accreditation changes and ensure the organization is in compliance with applicable laws and standards.
- Provide leadership and guidance to staff and other stakeholders on regulatory and accreditation standards.
- Collaborate with management and other departments to ensure the compliance program is being followed.
- Oversee and manage the organization’s internal audit and compliance processes.
- Establish and maintain relationships with regulatory and accreditation bodies.
- Prepare and submit required reports to regulatory and accreditation bodies.
- Monitor and report on compliance performance.
- Plan, provide, and document educational programs pertaining to regulatory compliance in human research protections, IRB review process and quality management for members of the IRB and administrative staff
- Investigate and resolve noncompliance matters and incoming concerns from research subjects
- Schedule, prepare, facilitate, and respond to sponsor/CRO audits.
- Coordinate and facilitate routine site audits.
- Oversee the ongoing development, implementation, review, and revisions to the Standard Operating Procedures (SOPs) and Appendices to comply with local, state, federal and applicable international laws, rules and regulations governing human subject protection.
- Stay current with industry trends and best practices.
- Bachelor’s Degree with 7+ years of clinical research experience
- CIP certification
- JD or Master’s Degree in a scientific or public health discipline preferred
- Proficient computer skills and working knowledge of MS Office products
- A demonstrated track record of effective leadership
- Strong knowledge of compliance requirements of all research related federal regulations governing human subject research. Regulatory requirements include, but are not limited to: FDA, DHHS/OHRP, GCP/ICH.
- Strong interpersonal, communication, analytical, and organizational skills
- Ability to lead a team of diverse units
- Ability to deal effectively with difficult situations
- Ability to work effectively with a wide range of internal and external stakeholders, including Board members, IRB administrative leadership, clients, and staff members
- Commitment to high ethical standards
- Ability to excel in a team environment
- Excellent organizational skills with great attention to detail
- Ability to analyze information and solve problems
- Advanced oral and written communication skills
- Excellent interpersonal skills to work effectively with others and provide high levels of customer service and handle sensitive and confidential situations
- Ability to manage conflicting demands and priorities
Headquartered in Atlanta, Georgia, Sterling IRB offers a full benefit package, including medical, dental, life insurance, paid vacation and holidays, 401K, and profit-sharing program. Relocation package available. If you are interested in joining Sterling, please submit your resume and salary requirements to Kathye Richards, Vice President of Client Services: firstname.lastname@example.org.