Job Summary
We are seeking a highly motivated and detail-oriented Regulatory Specialist to join our innovative team and provide regulatory leadership across all clinical trials and be responsible for the overall planning and direction of clinical regulatory activities. Must have experience. This role develops and implements strategies with the goal of approval of regulatory submission. The Regulatory Specialist will collaborate closely with the Compliance Director, Site Leads and Start-Up Lead to develop and coordinate regulatory strategies for submissions.

Responsibilities:

• Lead regulatory activities for all clinical trials, ensuring compliance with applicable regulations and guidelines.
• Direct and oversee short-term and long-term planning of regulatory submission initiatives.
• Develop and implement strategies for the earliest possible approval of regulatory submission and ensure all regulatory documents/logs are up to date.
• Complete Study-related IRB submissions, in a timely manner.
• Collaborate with internal teams, including Compliance, Site Leadership, and Study Start-Up to ensure timely and high-quality submissions.
• Serve as a regulatory resource for internal stakeholders, providing guidance on best practices and submission expectations.
• Manage regulatory elements and provide guidance to team.
• Plan, schedule and direct activities for study sponsor or monitors visits.
• Monitor regulatory requirements and industry trends to ensure ongoing compliance and proactive planning.
• Assist with outside agencies as needed to resolve key regulatory issues.
• Must attend meetings and share regulatory updates. Communicate changes and updates to staff and management, in a timely manner.
• Participate in audits and be audit ready at all times.
• Retrieve and distribute IRB approved documents, informed consents, and study-related documents in a timely manner.
• Coordinate and prepare document packages for regulatory submissions ensuring compliance.
• Assist with preparing outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to team.
• Educate Investigators, Coordinators, and other staff re: IRB and Regulatory standards and responsibilities.
• Create and maintain well organized, complete eRegulatory files.
• Ensure Delegation Logs are up to date at all times.
• Ensure staff is current on all general regulatory trainings.
• Other duties may be assigned.

Qualifications:

• Bachelor’s degree in life science, or related field required; equivalent education and relevant experience may be accepted.
• Requires 2-4 years of clinical research experience, primarily in developing and submitting successful regulatory submissions.
• Strong knowledge of IRB requirements and Federal and State regulations as they relate to research.
• Ability to manage multiple priorities and deadlines in a fast-paced environment.
• Effective communication and cross-functional collaboration skills.
• Ability to work independently with minimal supervision.
• Demonstrated excellent written, oral, communication, presentation, planning and interpersonal skills for effective collaboration with cross-functional teams and regulatory agencies
• Excellent organizational skills with a strong attention to detail.
• Critical thinker and problem solver.
• Professional, friendly, outgoing personality; maintain a positive attitude under pressure.
• Proficiency in Microsoft Office Suite.
• A high level of self-motivation and energy with an optimistic, “can do” attitude.

NexGen Research, LLC is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status, or any other characteristic protected by law.

Job Type: Full-time

Pay: $50,000.00 - $60,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Relocation assistance
• Vision insurance

Work Location: In person