Job Description
Job Description
The Clinical Research Regulatory Specialist will support clinical research activities across a multi-site research network by ensuring compliance with all applicable regulatory requirements. This role plays a key part in managing the regulatory aspects of clinical trials, partnering closely with cross-functional teams to support efficient and compliant processes from study initiation through closeout. The Regulatory Specialist will work with multiple research sites to streamline regulatory workflows and promote consistency and collaboration across studies.
Location: Fully Remote (CST time zone working hours)
Schedule: Monday-Friday around 8-5 CST but flexible as long as deadlines are hit on time!
Contract: 6 month contract to full-time hire after based on performance/attendance!
Paid weekly, benefits start after 30 days on contract (medical, dental, vision, etc)
Responsibilities
- Ensure compliance with all applicable regulatory requirements, including FDA regulations, ICH guidelines, and local regulatory standards.
- Prepare, submit, and maintain regulatory documents such as IND applications, amendments, and annual reports.
- Coordinate regulatory submissions to regulatory authorities and ethics committees, ensuring accuracy and timely completion.
- Review clinical trial protocols, informed consent forms, and study-related documents to confirm regulatory compliance.
- Review and revise study-specific informed consent forms to improve readability, clarify payment and cost language, define standard-of-care elements, and ensure all required FDA elements are included.
- Prepare, route, and submit essential regulatory documents to sponsors and CROs on behalf of participating research sites.
- Partner with investigators and study teams to address regulatory questions and provide guidance on compliance requirements.
- Support regulatory activities during study start-up, including obtaining approvals, organizing regulatory binders, and ensuring site readiness.
- Maintain complete, accurate, and audit-ready regulatory files and documentation.
- Establish and manage electronic regulatory binder systems to securely store and organize submissions and essential documents.
- Track regulatory timelines, milestones, and submission statuses, and communicate updates to internal stakeholders.
*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
*As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
For California Applicants:
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA).
This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
Company DescriptionHere at Medix, we are dedicated to providing workforce solutions to clients throughout multiple industries. We have been named among the Best and Brightest Companies to Work For in the Nation for two consecutive years. Medix has also been ranked as one of the fastest growing companies by Inc. Magazine.
Our commitment to our core purpose of positively impacting 20,000 lives affects not only the way we interact with our clients and talent, but also with our co-workers! The goal is lofty, but it is made attainable through the hard work and dedication of our teams and their willingness to lock arms together. Are you ready to lock arms with us?
Company Description
Here at Medix, we are dedicated to providing workforce solutions to clients throughout multiple industries. We have been named among the Best and Brightest Companies to Work For in the Nation for two consecutive years. Medix has also been ranked as one of the fastest growing companies by Inc. Magazine.\r\n\r\nOur commitment to our core purpose of positively impacting 20,000 lives affects not only the way we interact with our clients and talent, but also with our co-workers! The goal is lofty, but it is made attainable through the hard work and dedication of our teams and their willingness to lock arms together. Are you ready to lock arms with us?