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Job Title: Regulatory Affairs SpecialistJob Description

We are seeking a full-time Clinical Research & Regulatory Affairs Specialist to work remotely for at least six months, dedicated to the oncology research program. This role involves preparing and processing all regulatory documentation through IRB/CIRB, including new submissions, continuing reviews, amendments, adverse events, and reportable events, with minimal supervision. The specialist will also handle regulatory documentation for the NCI, organize and maintain all regulatory affairs documentation/files, resolve regulatory and data queries, and participate in monitoring, audit, and close-out visits as needed. Participation in study team meetings, research team meetings, and ongoing protocol training/compliance meetings is expected.

Responsibilities

+ Review, reconcile, and ensure compliance for an NCTN trial previously initiated under prior leadership.

+ Manage a large volume of data entry, query resolution, images for upload, and regulatory submissions to maintain regulatory compliance.

+ Submit final termination requests through CIRB for studies no longer active at the site.

+ Prepare and process regulatory documentation for IRB/CIRB, including new submissions, continuing reviews, amendments, adverse events, and reportable events.

+ Organize and maintain regulatory affairs documentation/files as required.

+ Resolve regulatory and data queries.

+ Participate in monitoring, audit, and close-out visits.

+ Attend study team meetings, research team meetings, and ongoing protocol training/compliance meetings.

Essential Skills

+ Regulatory Affairs expertise.

+ Active NCI RCR registration.

+ Experience managing high-risk NCTN biomedical research.

+ Advanced knowledge and ability to work within CTEP portal, RUMS rostering, OPEN/Rave database, and CIRB Manager.

Additional Skills & Qualifications

+ BS degree, preferably in a life science or human subject protection field.

+ 3-5 years of research experience.

+ At least 1 year of regulatory experience preferred.

Work Environment

This position is fully remote, allowing for flexible work arrangements from any location. The role is contingent on funding, with six months of funding secured and additional opportunities being explored.

Job Type & Location

This is a Contract position based out of Philadelphia, PA.

Pay and Benefits

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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Dec 25, 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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.