(CW) Sr. Study Specialist CONTRACT

About the role

The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). This may include contributing to and/or supporting study related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s).

Responsibilities

• Develop study specific documentation, as delegated by the Study Manager
• Contribute to the oversight of country and site feasibility assessment and site selection
• Oversight of CRO for IRB/EC related submission/approval activities
• Oversight of essential documents for study life-cycle management
• Develop/Oversee site and investigator training materials
• Present at investigator meetings as assigned
• Ensure accurate and timely study entry and updates to ClinicalTrials.gov
• Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
• Process documents for signature in DocuSign
• Oversight of Clinical Trial Insurance
• Attend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.
• Oversee and manage essential documents in the Trial Master File (TMF)
• Contribute to Global Study Operations risks identification and mitigations.
• Provide support and administrative assistance with internal and external meetings

Requirements

• BA/BS or higher in nursing, life or health sciences is preferred.
• Industry or relevant experience in lieu of education is considered.
• Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets, and contracts.

Qualifications

• Proven experience in clinical research and study management
• Strong communication and collaboration skills
• Ability to manage multiple projects simultaneously
• Knowledge of regulatory requirements and compliance standards
• Proficiency in Microsoft Office Suite

Skills

• Excellent organizational and time management skills
• Strong problem-solving and decision-making abilities
• Ability to work independently and as part of a team
• Effective written and verbal communication skills
• Ability to manage relationships with key stakeholders

Benefits

• Flexible work schedule
• Hybrid work option
• Competitive compensation package
• Health, dental, and vision insurance
• 401(k) retirement plan
• Employee Assistance Program (EAP)

Pay

Commensurate with experience

Schedule

Hybrid on Tues. and Thurs. in San Rafael or remote based employee within the US.