The
Clinical Research Safety Specialist plays a critical role in supporting regulatory compliance and patient safety across clinical research studies. Primary responsibilities include preparing and submitting documentation to Institutional Review Boards (IRBs), maintaining regulatory files related to IND Safety Reports and Investigator Brochures, and ensuring accurate and timely documentation throughout the lifecycle of clinical trials.
In addition, this position supports regulatory affairs activities for both industry-sponsored and investigator-initiated studies, helping to ensure ongoing compliance with applicable regulations, protocols, and sponsor requirements. The
Clinical Research Safety Specialist collaborates closely with Regulatory Affairs leadership, study teams, and Principal Investigators to facilitate regulatory processes, maintain inspection readiness, and support internal and external audit activities.
This is a remote position based in the US; relocation assistance, and visa sponsorship are not available.Key Responsibilities:- Prepare and submit regulatory documents to Institutional Review Boards (IRBs) and other applicable oversight bodies.
- Maintain and organize IND Safety Reports, Investigator Brochures, and other essential regulatory documentation.
- Monitor and support compliance with federal regulations, sponsor requirements, and institutional policies.
- Assist with regulatory submissions and ongoing regulatory affairs activities for industry-sponsored and investigator-initiated clinical trials.
- Partner with Regulatory Affairs leadership, study teams, and Principal Investigators to ensure regulatory requirements are met.
- Support audit and inspection readiness by maintaining complete, accurate, and current regulatory files.
- Track deadlines and manage multiple priorities while ensuring timely completion of submissions and compliance-related activities.
- Other duties as assigned
This role requires exceptional attention to detail, strong organizational skills, and the ability to work effectively in a fast-paced clinical research environment while managing competing priorities and regulatory deadlines.
Qualifications needed for success include:- Bachelor's Degree required
- Minimum 1+ years' professional work experience in a clinical research, biotechnology, life sciences, pharmaceutical or hospital environment
- Work experience should include knowledge of IRB, FDA, and GCP guidelines required
- Work experience of scientific and clinical research terminology required
- Above average skills with all MS Office products including Excel, Word, Outlook
- Exceptional organizational skills required
We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
