(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.

Responsibilities

• Develop study specific documentation, as delegated by the Study Manager.
• 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.
• 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 other study related matters is required.

Qualifications

• Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets, and other study related matters is required.

Skills

• Agility and Proactivity.
• Leadership.
• Communication and Collaboration.

Benefits

Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Pay

Not specified

Schedule

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