About the Role
The Study Activation Specialist supports the launch of clinical trials by managing regulatory submissions, site training, and activation milestones. This role ensures adherence to protocols, timelines, and compliance standards across decentralized research locations.
Responsibilities
- Coordinate regulatory document collection and site initiation activities for clinical trial sites
- Ensure submission packages meet sponsor and regulatory requirements
- Track activation timelines and maintain accurate study records
- Collaborate with cross-functional teams to resolve site-specific activation barriers
- Verify site compliance with protocol and regulatory guidelines
- Support the preparation and distribution of site-specific activation materials
- Monitor progress toward site activation goals and report status updates
- Assist in the review of informed consent forms and site regulatory files
- Facilitate communication between internal teams and external research sites
- Maintain up-to-date knowledge of clinical trial regulations and internal processes
- Participate in process improvement initiatives related to study start-up efficiency
- Ensure electronic regulatory binder accuracy and completeness
- Respond to site inquiries regarding activation requirements
- Assist with onboarding new sites onto trial management systems
- Track regulatory approvals and coordinate activation milestones
- Support audit readiness for site documentation
- Manage document expiration alerts and re-certification processes
- Liaise with legal and contracts teams when necessary
- Provide status reports on activation progress to project leads
- Ensure consistent application of standard operating procedures across sites
- Assist in training materials development for site staff
- Coordinate translation requirements for site documents when needed
- Maintain confidentiality of study and patient information
- Adapt workflows based on sponsor-specific requirements
- Escalate critical delays or compliance concerns promptly
Compensation
Competitive salary and benefits package
Work Arrangement
Remote within the United States
Team
Part of a national clinical research operations team supporting oncology trials
Why Join Us
- Opportunity to contribute to innovative cancer research initiatives
- Supportive team environment focused on professional growth
- Remote flexibility with structured collaboration tools
- Exposure to diverse clinical trial designs and therapeutic approaches
Physical Requirements
- Position is fully remote with no physical demands beyond standard office work
- Regular use of computer and phone for virtual collaboration
Not available for this position
