Clincal study specialist

Responsibilities

• Oversee CRO activities, country/site feasibility assessments, and IRB/EC submission and approval workflows.
• Develop study-specific documentation, site investigator training materials, and present at investigator meetings.
• Manage end-to-end clinical trial milestones across start-up, maintenance, and close-out phases.
• Utilize core clinical systems (eTMF, EDC, IRT, and eCOA) to ensure data integrity, inspection readiness, and KPI tracking.
• Identify operational risks, develop mitigation strategies, and manage complex vendor escalations.

Qualifications

• Extensive biotechnology or pharmaceutical industry experience.
• Proven experience overseeing external clinical vendors (CROs, central labs, imaging) including SOWs, budgets, and invoices.
• Proficient with clinical systems including eTMF and EDC.
• Deep understanding of clinical trial lifecycles, critical path dependencies, and inspection-readiness.
• Bachelor’s degree (BA/BS) or higher in nursing, life sciences, or health sciences.

Skills

• EDC (Electronic Data Capture)
• Electronic Data Capture (EDC)
• Trial Master File (TMF)
• Electronic Trial Master File (eTMF)

Benefits

• Medical
• Prescription
• Dental
• Vision
• AD&D
• Life Insurance
• Short-term Disability
• 401K Plan

Pay

Salary offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Schedule

This is a hybrid role (onsite Tuesdays and Thursdays).

Location

San Rafael, California

Job Type

Contract

Salary Range

$60.00 - 63.80 per hour

Work Hours

9 to 5

Education

Bachelor's degree (BA/BS) or higher in nursing, life sciences, or health sciences.

Equal Opportunity Employer

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Application Instructions

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Equal Opportunity Employer

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.