Clinical Trial Specialist
Tucker Parker Smith Group (TPS Group), San Rafael, CA, United States
Job Title:
Sr. Study Specialist, Global Study Operations
Duration:
6-Month Contract (Potential to Extend/Convert)
Location:
San Rafael, CA (Hybrid – Onsite Tuesdays & Thursdays)
Pay Rate:
$54–56/hour
About the Company
A leading biotechnology organization focused on developing innovative therapies for patients with serious and life‑threatening rare genetic diseases. The company is dedicated to advancing treatment options, improving patient outcomes, and supporting underserved patient populations globally.
Position Summary
The Sr. Study Specialist (SS) plays a critical role within Global Study Operations, supporting the execution and oversight of clinical trials. This individual will contribute to or lead key operational activities including site monitoring oversight, vendor management, and study execution support.
This role requires a strong understanding of the clinical trial lifecycle, the ability to manage complex operational tasks independently, and a focus on ensuring study quality, timelines, and compliance.
Key Responsibilities
Develop and manage study‑specific documentation in collaboration with Study Managers
Support feasibility assessments, site selection, and site start‑up activities
Oversee CRO activities, including IRB/EC submissions and approvals
Manage essential documents throughout the study lifecycle (TMF/eTMF)
Develop and oversee site and investigator training materials
Participate in and present at investigator meetings as needed
Ensure accuracy and timeliness of study‑related data and documentation
Oversee Clinical Trial Insurance activities
Manage updates to ClinicalTrials.gov
Track Screening Authorization Forms and study‑related documentation
Facilitate document execution through DocuSign
Identify study risks and support mitigation strategies
Participate in cross‑functional, vendor, and study execution meetings
Provide administrative and operational support for internal and external meetings
Clinical study management and execution
Compliance, quality, and inspection readiness
Drug development and clinical study design understanding
Therapeutic area and product knowledge
Systems & Tools
TMF/eTMF systems (quality and inspection readiness)
EDC systems (operational workflows and timelines)
IRT/IXRS and eCOA/ePRO platforms
Vendor and site tracking tools (KPIs, milestones)
Microsoft Teams and SharePoint
Strong focus on data integrity and system accuracy
Qualifications
Bachelor's degree in life sciences, nursing, or related field (or equivalent experience)
Experience in biotech or pharmaceutical industry
Familiarity with budgets, SOWs, POs, and invoice management
Strong understanding of clinical trial lifecycle (start‑up through close‑out)
Ability to work independently in a fast‑paced, complex environment
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Sr. Study Specialist, Global Study Operations
Duration:
6-Month Contract (Potential to Extend/Convert)
Location:
San Rafael, CA (Hybrid – Onsite Tuesdays & Thursdays)
Pay Rate:
$54–56/hour
About the Company
A leading biotechnology organization focused on developing innovative therapies for patients with serious and life‑threatening rare genetic diseases. The company is dedicated to advancing treatment options, improving patient outcomes, and supporting underserved patient populations globally.
Position Summary
The Sr. Study Specialist (SS) plays a critical role within Global Study Operations, supporting the execution and oversight of clinical trials. This individual will contribute to or lead key operational activities including site monitoring oversight, vendor management, and study execution support.
This role requires a strong understanding of the clinical trial lifecycle, the ability to manage complex operational tasks independently, and a focus on ensuring study quality, timelines, and compliance.
Key Responsibilities
Develop and manage study‑specific documentation in collaboration with Study Managers
Support feasibility assessments, site selection, and site start‑up activities
Oversee CRO activities, including IRB/EC submissions and approvals
Manage essential documents throughout the study lifecycle (TMF/eTMF)
Develop and oversee site and investigator training materials
Participate in and present at investigator meetings as needed
Ensure accuracy and timeliness of study‑related data and documentation
Oversee Clinical Trial Insurance activities
Manage updates to ClinicalTrials.gov
Track Screening Authorization Forms and study‑related documentation
Facilitate document execution through DocuSign
Identify study risks and support mitigation strategies
Participate in cross‑functional, vendor, and study execution meetings
Provide administrative and operational support for internal and external meetings
Clinical study management and execution
Compliance, quality, and inspection readiness
Drug development and clinical study design understanding
Therapeutic area and product knowledge
Systems & Tools
TMF/eTMF systems (quality and inspection readiness)
EDC systems (operational workflows and timelines)
IRT/IXRS and eCOA/ePRO platforms
Vendor and site tracking tools (KPIs, milestones)
Microsoft Teams and SharePoint
Strong focus on data integrity and system accuracy
Qualifications
Bachelor's degree in life sciences, nursing, or related field (or equivalent experience)
Experience in biotech or pharmaceutical industry
Familiarity with budgets, SOWs, POs, and invoice management
Strong understanding of clinical trial lifecycle (start‑up through close‑out)
Ability to work independently in a fast‑paced, complex environment
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