Clinical Study Specialist

Job Title : Clinical Study Specialist

Location : San Rafael, CA Hybrid (2 days onsite)

Experience : 6+ Years

Duration : 12+ months

Overview :

The Clinical Study Specialist plays a critical role in supporting and overseeing study activities, including site monitoring, vendor management, and other tasks delegated by the Study Manager or Program Lead (PL). The SS ensures study participant safety, data integrity, compliance, and timely execution while managing complex vendors, sites, and regions. This role requires a high level of independence, strong problem-solving skills, and effective relationship management with key investigators and external vendors.

Key Responsibilities :

Develop and maintain study-specific documentation as delegated by the Study Manager.

Support country and site feasibility assessments and site selection processes.

Oversee CRO activities related to IRB / EC submissions and approvals.

Ensure accurate management of essential documents throughout the study lifecycle.

Develop and oversee site and investigator training materials.

Present at investigator meetings as assigned.

Maintain accurate and timely study updates in ClinicalTrials.gov.

Facilitate Screening Authorization Form sign-offs and tracking, when applicable.

Process documents for signature using DocuSign.

Oversee Clinical Trial Insurance activities.

Attend Global Study Operations team, vendor, and cross-functional meetings as a representative and take meeting minutes as requested.

Manage and maintain essential documents in the Trial Master File (TMF).

Contribute to risk identification and mitigation strategies within Global Study Operations.

Provide administrative support for internal and external meetings.

Required Competencies :

Study Management and Execution

Compliance and Quality

Drug Development and Study Design

Product and Therapeutic Area Knowledge

Experience and Qualifications :

Experience in a biotechnology or pharmaceutical company.

Proven ability to oversee external vendors, including SOWs, budgets, POs, and invoice management (CROs, central labs, imaging, etc.).

Strong organizational, communication, and problem-solving skills.

Demonstrated ability to work independently and manage complex study-related tasks.