- Experience
- 3+ yrs
- Salary
- USD 24 – USD 28 / hour
- Openings
- 1
- Posted
- 5 days ago
- Work mode
- Work from home
- Education
- Bachelor's degree or equivalent education and experience
- Resume
- Required to apply
Job description
About the Company
The organization is a rapidly expanding clinical research network operating over 30 sites across more than 10 states. It supports studies in various therapeutic areas such as cardiology, oncology, metabolic disorders, neuroscience, pulmonology, renal disease, and vaccines. The company fosters a collaborative, entrepreneurial workplace devoted to advancing research and enhancing patient care.
Position Overview
This fully remote opportunity is for a Regulatory Specialist to oversee regulatory compliance in clinical research studies. Responsibilities include managing study documentation, coordinating submissions to regulatory bodies, and maintaining inspection-ready files. The role requires a detail-oriented, self-motivated individual capable of collaborating with multiple teams in different locations.
Key Responsibilities
- Organize, prepare, and manage regulatory documents for clinical research studies.
- Coordinate initial, ongoing, amended, and final submissions to Institutional Review Boards (IRBs), sponsors, and regulatory agencies.
- Maintain regulatory binders, study logs, informed consent forms, FDA Form 1572s, safety data, and investigator documentation.
- Assemble regulatory files and supporting materials for sponsor monitoring, inspections, and audits.
- Monitor and track employee credentials, including résumés, licenses, certifications, training records, and related documents.
- Assist with document archiving, process improvements, departmental projects, and training of newer staff members.
Candidate Qualifications
- Bachelor's degree or comparable education plus relevant experience.
- Minimum of three years’ experience in clinical research, biological research, or a related field.
- Comprehensive understanding of clinical research workflows, regulatory documentation, IRB requirements, and sponsor standards.
- Exceptional attention to detail, strong organizational skills, and ability to prioritize multiple tasks effectively.
- Proficiency with Microsoft Outlook, Word, Excel, and web-based applications.
- Excellent written communication, critical thinking, teamwork, and independent problem-solving abilities.
Additional Information
- This is a 100% remote position.
- Hourly pay ranges between $24 and $28.
- The company offers robust benefits including health insurance, 401(k) matching, tuition reimbursement, paid leave, and disability coverage.
- There is significant potential for career growth within a dynamic, expanding clinical research environment.