Regulatory Specialist- Clinical Research

The Regulatory Specialist promotes compliance with federal regulations, Good Clinical Practice (GCP), and institutional policies for clinical trials. This role serves as a key liaison among investigators, internal departments, institutional review boards (IRBs), and external regulatory agencies to support the safe and compliant conduct of clinical research. The position focuses on managing regulatory documentation, facilitating IRB submissions, and ensuring that all regulatory requirements for clinical studies are met in a timely and accurate manner.

Responsibilities

• Organize and maintain regulatory binders, including filing essential documents and obtaining required signatures for delegation logs, training logs, and other critical study records.
• Review sponsor template and site-level informed consent forms (ICFs) to ensure compliance with GCP and International Conference on Harmonisation (ICH) guidelines.
• Participate in the regulatory review, preparation, and submission of clinical study documentation such as investigator brochures, Investigational Device Exemptions (IDE), Investigational New Drug (IND) applications, and treatment or compassionate/emergent use documents.
• Ensure timely and accurate submission of all protocol amendments, ICFs, investigator brochures, and other administrative items to the IRB of record.
• Arrange for the receipt and transmission of administrative and regulatory documents, and file Serious Adverse Event (SAE) and IND safety reports as required.
• Review and interpret IRB correspondence with the research team and promptly notify team members of determinations that may affect the safety and welfare of human subjects.
• Obtain and maintain updated laboratory and test reference ranges for use in clinical research documentation and review.
• Update electronic databases to reflect personnel changes and ensure that regulatory records remain current and accurate.
• Act as a liaison between investigators, sponsors and their representatives, and the IRB on all regulatory issues related to clinical trials.
• Assist investigators in obtaining necessary system access and approvals to support research readiness and study start-up.
• Provide timely follow-up on regulatory issues, resolve problems, prepare update reports, and escalate concerns as appropriate.
• Attend and actively participate in study team meetings, sponsor meetings, research meetings, and conferences or in-service education sessions as required.
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Essential Skills

• Clinical trial regulatory experience, including direct interaction with institutional review boards (IRBs) and maintaining components of clinical trial conduct.
• Experience dealing with IRBs, including preparing, submitting, and tracking regulatory documents and correspondence.
• Demonstrated ability to maintain and manage regulatory documentation, including regulatory binders and essential study documents.
• Bachelors degree (BA/BS) in a science, healthcare, or communications field, or equivalent combination of related education and experience.
• Strong attention to detail with a commitment to accuracy and compliance in regulatory work.

Additional Skills & Qualifications

• Minimum of 3 years of experience in clinical research or a related regulatory area is preferred.
• Formal education or training in human subjects research and Good Clinical Practice (GCP) is preferred.
• Knowledge of clinical trial processes and lifecycle, including start-up, conduct, and close-out.
• Familiarity with basic scientific principles relevant to clinical research and regulatory oversight.
• Ability to work effectively in a fast-paced environment and manage competing tasks and demands.
• Experience within an oncology or cancer research setting is beneficial, given the cancer center environment.
• Interest in ongoing professional development, including reading related literature, attending training classes, and participating in professional meetings.

Job Type & Location

This is a Contract to Hire position based out of Hackensack, NJ.

The pay range for this position is $30.00 - $35.00/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 Hackensack,NJ.

This position is anticipated to close on Jun 12, 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 30,000 consultants and more than 4,500 clients across the U.S.,

Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 ... 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.