Clinical Regulatory Coordinator

Job Description

We are seeking a Clinical Regulatory Coordinator to manage, submit, and maintain regulatory documents for IRB and sponsor submissions across multiple studies. This role involves ensuring all study documentation complies with GCP, FDA regulations, and institutional policies. You will maintain regulatory binders and essential study documentation across all active and archived studies, track protocol amendments, safety reports, and correspondence with regulatory bodies. Additionally, you will coordinate and support site initiation visits, monitoring visits, audits, and inspections from a regulatory perspective.

Responsibilities

• Manage, submit, and maintain regulatory documents for IRB and sponsor submissions across multiple studies.
• Ensure all study documentation complies with GCP, FDA regulations, and institutional policies.
• Maintain regulatory binders and essential study documentation across all active and archived studies.
• Track protocol amendments, safety reports, and correspondence with regulatory bodies.
• Coordinate and support site initiation visits, monitoring visits, audits, and inspections from a regulatory perspective.
• Work collaboratively with clinical and operations staff to ensure timely startup and regulatory readiness.
• Assist in developing SOPs and regulatory workflows to support regulatory operations.
• Provide on-site regulatory support for trial sites during SIVs, monitoring visits, and other ad hoc visits as needed.

Essential Skills

• 4 years of experience in clinical research regulatory coordination.
• Deep understanding of FDA regulations, GCP, and IRB processes.
• Experience completing internal/external audits.
• Strong organizational skills and attention to detail.
• Ability to manage multiple studies and deadlines simultaneously.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office and electronic regulatory systems.
• Willingness and ability to travel (up to 25%) across sites.

Additional Skills & Qualifications

• Outgoing and confident.
• Team player.
• Flexible and agile with a sense of urgency.
• Ability to remain calm and composed during changes.
• Assertive in communication with doctors.

Work Environment

This role requires 100% on-site presence with up to 25% travel between sites in LA, Las Vegas, Texas, and DC. Travel planning is provided with a 2-week advance notice. You will work with several satellite sites in a site network organization (SMO) and need to be a critical thinker due to varying conditions across sites and PIs. Current therapeutic areas include Ophthalmology, Dermatology, NASH, and Neurology.

Pay and Benefits

The pay range for this position is $50000.00 - $85000.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Los Angeles,CA.

Application Deadline

This position is anticipated to close on Apr 18, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $50,000 - $85,000