What are the responsibilities and job description for the Regulatory Specialist position at Actalent?
Clinical Research Regulatory Coordinator
Job Summary: The Clinical Research Regulatory Coordinator is responsible for managing and executing the regulatory compliance activities of clinical research studies. This role ensures that all research activities are conducted in accordance with Good Clinical Practice (GCP) guidelines, federal regulations, and institutional policies. This position focuses within oncology clinical research trials, where the workload will be handling approximately 30 clinical trials at a given time within Phases II-IV.
Key Responsibilities:
- Ensure compliance with all regulatory requirements, including Institutional Review Board (IRB) submissions, amendments, safety reports, and renewals.
- Maintain and update regulatory files in both paper and electronic formats, ensuring they are audit-ready at all times.
- Prepare, manage, and submit protocol documents, including informed consent materials, conflict-of-interest forms, and serious adverse event (SAE) forms.
- Work closely with Principal Investigators (PIs), sponsors, and other stakeholders to complete required regulatory documents and facilitate study activation and amendments.
- Develop and implement quality control systems to reduce errors and ensure the integrity of research data.
- Assist in the development and implementation of Standard Operating Procedures (SOPs) and provide training and mentorship to research staff as needed.
- Participate in internal and external audits, addressing compliance-related findings in a timely manner.
Qualifications:
- Experience with regulatory documentation and processes.
- MUST have Clinical Research experience.
- Knowledge of GCP, FDA regulations, and IRB processes.
- Strong organizational and communication skills.
Preferred Qualifications:
- Certification in clinical research (e.g., ACRP/SOCRA)
- Experience with electronic regulatory management systems, like OnCore.
- Experience within oncology highly preferred, but not required since it will be taught!
Working Conditions:
- This position is hybrid, with a requirement to come onsite 3 days per week. The remaining 2 days of the week will allow for remote work.
- The first month of employment is expected to be worked onsite while completing training and onboarding.
- Parking is paid for employees.
- Working amongst a welcoming and fostering team in a growing institution!
Pay and Benefits
The pay range for this position is $25.12 - $41.25
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 hybrid position in Detroit,MI.
Application Deadline
This position will be accepting applications until Jan 20, 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 : $25 - $41
