Regulatory Associate

Job Description

Job Description

Job Title: Regulatory Associate – Oncology (Thoracic Disease Group)

The Regulatory Associate supports oncology clinical research within the Thoracic disease group by managing regulatory maintenance activities for approximately 30 phase II–IV clinical trials. This role focuses on preparing and submitting regulatory documents, coordinating IRB submissions, maintaining study records, and ensuring monitors and study teams have appropriate system access. The Regulatory Associate works closely with Clinical Research Coordinators and Data Coordinators to ensure regulatory compliance, data integrity, and smooth study operations in a collaborative and growth-oriented environment.

Responsibilities

• Support all regulatory maintenance activities for oncology clinical trials within the Thoracic disease group, including managing documentation for approximately 30 phase II–IV studies.
• Prepare, submit, and track IRB submissions to both local and central IRBs, including Advarra and WCG, ensuring accuracy, completeness, and compliance with regulatory requirements.
• Manage regulatory documents such as protocol amendments, consent form changes, financial disclosures, and delegation of authority logs, ensuring they remain current and properly filed.
• Add and update study personnel on clinical trials, ensuring all required documentation and approvals are in place before individuals are engaged in study activities.
• Review regulatory information and upload all required documents to the appropriate systems and portals in a timely and organized manner.
• Assist with monitor visits by coordinating logistics, ensuring monitors have appropriate access to systems, and providing requested regulatory documentation.
• Respond promptly and professionally to email inquiries related to regulatory matters, study documentation, and trial status.
• Collaborate closely with Clinical Research Coordinators and Data Coordinators on the Thoracic team to support study start-up, maintenance, and close-out activities.
• Maintain thorough, accurate, and audit-ready regulatory files that align with institutional, sponsor, and regulatory guidelines.
• Support investigator-initiated IND studies by assisting with relevant regulatory submissions and documentation, as applicable.
• Participate in ongoing process improvements within the regulatory team, contributing to a collaborative, supportive, and solution-focused work environment.

Essential Skills

• Experience in regulatory affairs or regulatory support within clinical research.
• Hands-on experience with IRB submissions, including preparation and submission of materials to local and central IRBs (such as Advarra and WCG).
• Demonstrated ability to manage regulatory documents, including protocol amendments, consent changes, financial disclosures, and delegation of authority logs.
• Familiarity with oncology clinical research and the regulatory requirements associated with oncology trials.
• Strong organizational skills with the ability to manage multiple concurrent studies and deadlines.
• Proficiency in reviewing, organizing, and uploading documents into electronic systems and portals.
• Effective written and verbal communication skills to interact with monitors, coordinators, and other research team members.
• Ability to work both independently and collaboratively within a multidisciplinary research team.
• Strong attention to detail and commitment to regulatory compliance and data integrity.

Additional Skills & Qualifications

• Experience working specifically with oncology trials, particularly within a Thoracic disease group, is a plus.
• Familiarity with OnCore or similar clinical trial management systems is preferred.
• Experience supporting investigator-initiated IND studies is advantageous.
• Experience with IBC (Institutional Biosafety Committee) submissions is a plus.
• SOCRA or ACRP certification, or active pursuit of these certifications, is highly valued; reimbursement for certification costs may be available upon successful completion.
• Interest in professional growth within clinical research and regulatory affairs, with a desire to advance along a structured career ladder and into potential leadership roles.

Work Environment

This is a full-time, hourly position scheduled for 40 hours per week within a shift window of 6:30 a.m. to 9:30 p.m., with an 8.5-hour workday that includes a 30-minute unpaid lunch (requiring clock-out) and two paid 15-minute breaks. The role follows a hybrid onsite model, with an expectation to work onsite two days per week on flexible days, coordinated via shared calendars for visibility and team collaboration. During the first month, the position requires five days per week in-office for comprehensive training and onboarding. The environment is office-based and team-oriented, with a supportive regulatory group that values collaboration, welcomes new team members, and encourages professional development. The organization is growing through hospital expansion and strategic partnerships, offering job stability, opportunities for advancement, and a broader career ladder, including potential leadership roles. Professional attire appropriate for an office and clinical research setting is expected.

This is a Contract to Hire position based out of Detroit, MI.

The pay range for this position is $25.12 - $41.25/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 Detroit,MI.

This position is anticipated to close on Jun 26, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.