Regulatory Coordinator

Regulatory Coordinator

Job Description

The Regulatory Coordinator is responsible for preparing and submitting moderately complex protocols and supporting documentation to regulatory bodies and research committees involved in both the pre-award and post-award processes. This role also involves submitting continuations, amendments to regulatory bodies, and responding to a broad range of questions. The coordinator generates reports and maintains files and documentation to ensure compliance with regulatory requirements from federal and local agencies, including the Food and Drug Administration and Local Institutional Review Board, for assigned studies and/or clinical trials.

Responsibilities

• Submit continuations and amendments to ensure compliance with regulatory requirements and institutional policies.
• Complete forms and generate reports from multiple data sources to comply with assigned protocols for the study and/or clinical trial.
• Maintain research files and potentially audit documentation pertaining to regulatory requirements for clinical trials.
• Respond to generally broad data requests and questions.
• Monitor the status of assigned regulatory submissions and amendments from start to finish.
• Partner with research staff and investigators to ensure that all regulatory documents for assigned research studies are up to date.
• Represent the unit in cross-functional meetings and provide updates on the status of assigned regulatory submissions.
• Support the unit in internal and external auditing of regulatory documents.
• Identify quality and performance improvement opportunities to support efficient workflows.
• Maintain strict patient confidentiality according to HIPAA regulations and follow guidance according to applicable law, using Good Clinical Practice (GCP) guidelines.

Essential Skills

• Experience in regulatory affairs and good knowledge of federal and local regulatory requirements.
• Proficiency in regulatory, IRB, clinical research, oncology, and clinical trial processes.
• Ability to manage budgeting in a clinical research setting.

Additional Skills & Qualifications

• Bachelor's Degree required.
• 3 years of experience in clinical research or a related field.
• Certification in Clinical Research from SOCRA or ACRP is preferred.

Work Environment

This role is primarily hybrid with an expectation to be on-site once a month, although this can change. Initially, the position requires being on-site five times a week for the first few months for training purposes. The study load includes managing 12-15 study start-ups at all times, particularly in phase I. The organization is renowned for developing new cancer therapies, offering both experimental and traditional treatments, and providing guidance and training for the next generation of clinicians.

This is a Contract to Hire position based out of Los Angeles, CA.

The pay range for this position is $40.00 - $45.00/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)

This is a hybrid position in Los Angeles,CA.

This position is anticipated to close on Apr 2, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $40 - $45