Sr. Study Specialist

Tucker Parker Smith Group (TPS Group)

San Rafael, CA

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JOB DETAILS

SALARY

SKILLS

Administrative Skills, Biology, Biotech and Pharmaceutical, Budgeting, Clinical Study Publications, Clinical Trial, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Data Quality, Document Management, Documentation, Drug Development, Electronic Data Capture (EDC), Equal Credit Opportunity Act (ECOA), Feasibility Analysis, Genetic Diseases, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Insurance, Leadership, Microsoft Product Family, Microsoft SharePoint, Nursing, Operational Support, Operations Management, Patient Care, Performance Metrics, Problem Solving Skills, Risk Analysis, Risk Management, Site Evaluation, Startup, Statement of Work (SOW), System Operations, Vendor/Supplier Management

LOCATION

San Rafael, CA

POSTED

18 days ago

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: $58 60/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

Core Competencies

Agility and proactive problem-solving
Strong leadership and accountability
Effective communication and cross-functional collaboration

Technical Competencies

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
Experience managing external vendors (CROs, labs, imaging vendors, etc.)
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

Please submit your resume in Word or PDF format to be considered.