What are the responsibilities and job description for the Senior Clinical Trial Specialist – Global Studies position at Staffana?
Sr. Study Specialist – Global Study Operations
Location: San Rafael, CA (Hybrid – Tues & Thurs onsite)
Duration: 6 Months Contract
Work Model: Hybrid (Offsite 2 days onsite)
Pay Rate: $50/hr to $58/hr (W2) - Based on experience
About the Role
The Sr. Study Specialist (SS) supports and executes global clinical study operations, working closely with Study Managers and Program Leads. This role involves site monitoring oversight, vendor management, and study execution support across the full clinical trial lifecycle.
You will play a key role in ensuring patient safety, data integrity, regulatory compliance, and study timelines in a fast-paced and complex clinical trial environment.
Key Responsibilities
- Support or lead study operational activities across startup, maintenance, and closeout phases
- Contribute to site feasibility, selection, and activation processes
- Oversee CRO activities, including IRB/EC submissions and approvals
- Manage trial master file (TMF/eTMF) to ensure inspection readiness
- Coordinate site & investigator training materials and presentations
- Track and oversee ClinicalTrials.gov updates and compliance
- Handle vendor management (budgets, SOWs, invoices, performance tracking)
- Monitor study timelines, risks, and issue escalations
- Support cross-functional collaboration across global teams
- Ensure accurate documentation, reporting, and system updates
- Assist in audit/inspection readiness activities
Required Skills & Experience
Core Competencies
- Strong communication & cross-functional collaboration
- Ability to work independently in complex environments
- Proactive mindset with strong problem-solving skills
- Demonstrated leadership and ownership
Technical Expertise
- End-to-end clinical trial lifecycle experience
- Strong understanding of:
- Study startup, execution, and closeout
- Regulatory compliance and GCP standards
- Clinical development processes
Experience with:
- eTMF/TMF systems (quality & inspection readiness)
- EDC systems
- IRT/IXRS, eCOA/ePRO platforms
- Vendor and site performance tracking (KPIs)
Tools: Microsoft Teams, SharePoint, DocuSign
Education & Qualifications
- Bachelor’s degree in Life Sciences, Nursing, or related field (preferred)
- Equivalent industry experience will be considered
- Experience in biotech/pharma clinical operations required
Proven experience managing:
- CROs and external vendors
- Study budgets, POs, and invoices
Ideal Candidate Profile
- 5–8 years in clinical study operations or clinical trial management
- Strong experience with global trials and CRO oversight
- Comfortable working in a fast-paced, matrixed environment
- Prior experience in rare disease or complex trials is a plus
Salary : $50 - $58