Icon hamburger
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.

Regulatory Specialist

Medix Hackensack Full-Time
Apply Now

Position Summary

Regulatory Coordinator will be responsible for all aspects of clinical research regulatory compliance, including document preparation, submission, and management, for a specified portfolio of clinical trials.

Essential Functions:

Coordinate the preparation and timely submission of regulatory documents to the local Institutional Review Board (IRB), Cancer Protocol Review and Monitoring Committee (CPRMC), Data Safety and Monitoring Board (DSMB), other internal committees, national cooperative groups, industrial clinical research sponsors, and Contract Research Organizations (CRO's) as necessary to meet all internal and external regulatory compliance standards. Responsibilities include, but are not limited to:

Initial review of research protocols and informed consent documents,

  • Preparation and submission of protocol amendments, continuations, adverse events, and document addendums
  • Assistance with FDA and NCI submissions in collaboration with other City of Hope departments and Regulatory Affairs Offices.

Assist in gathering information from Study Coordinators, Physicians, other staff, and study sponsors as needed for the submission of regulatory documents.

Assists Regulatory Manager with aspects of the research trials regulatory process to include:

  • Prepare routine protocol status reports for the CTO office, Investigators, and research staff.
  • Oversee and maintain documentation of correspondence to and from the IRB
  • Assist COH researchers in study design, consent form creation and compliance with IRB requirements.
  • Communicate to CTO staff relevant aspects of the regulatory process and requirements for protocol development and conduct of research trials.

Assist in maintaining master regulatory files in accordance with institutional, state and federal regulations.

Assist with updating the medical and CTO staff with regards to institutional requirements for protocol development and conduct of research trials.


1) Minimum of 6 months - 1 year of experience as a Regulatory Coordinator in a Clinical Research setting

2) Strong Communication Skills

3) Takes Initiative

4) Teamwork and Collaboration


Recommended skills

Clinical Trials
Clinical Research


About the company

Salary Estimator

Based on Job Title, Location and Skills
Below Avg. Average Above Avg.
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

Job ID: 82295


For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.

Launched in 2001, Medix was built on the principle of becoming a leading provider of workforce solutions for clients and candidates across the Healthcare, Scientific and Information Technology industries. As we grow and evolve, we recognize our differentiation lies not just in traditional staffing, but in true partnerships and collaboration on hiring solutions.

We bring value to our talent by helping them identify their individual skills and aptitudes, matching them with opportunities to excel and creating communities where they can foster their skills and always have a trusted partner in their career.

In supporting our clients, we understand that each organization and culture is unique, and we thrive in collaborating with our clients to provide innovative solutions to suit their specific needs.

The root of our growth and continued success stems from not only our loyal clients and talent, but the dedication of our people. Medix takes great pride in our teammates and the culture we built together as an organization. We promote an environment that rewards the hard work and perseverance necessary to solve the unique needs of our clients and talent. The Medix family might span across the country, but our team is tightly united around our core purpose, core values and our mission to provide superior service to our customers.

Join Medix Talent Network

View the full profile