Primary RoleThe Clinical Trial Associate (CTA) position is responsible for the support of the study team by creating, distributing, maintaining, and organizing study materials, tools and documents to ensure conduct of clinical trials is in compliance with protocol requirements, SOPs and ICH GCP Guidelines. Additional responsibilities include general administrative support to the Clinical Operations Department.
What you'll do- Set up, organize, and maintain clinical study documentation, study level files and overall filing of study-specific documentation
- Assist in the start-up, management, close-out and reporting of assigned clinical studies
- Coordination of vendor supplies, tracking of inventory and study materials
- Participate in vendor User Acceptance Testing (UAT) activities
- Coordination of document translations, if required
- Assist in budget tracking and invoice review, data entry, and processing of investigator payments
- Liaise with the sites for specific requests (e.g., enrollment logs, missing documentation, meeting arrangements)
- Tracking and distribution of safety reports, as applicable
- Attend project meetings and generate meeting minutes
- Assist in the collection of ICH essential documents ensuring TMF is complete and appropriately maintained
- Assist in the preparation of project status reports for management review
- Maintain, update, and establish various databases and metrics to support Sponsor oversight responsibilities
- Ensure appropriate documentation of all identified site- and protocol-related issues
- Partner with Clinical Research Associate (CRA) to ensure completeness and accuracy of eISF and eTMF
- Facilitate posting and updates to Clinicaltrials.gov
- Other responsibilities as assigned
LocationIn office, Mountain View, CA
Salary Range$80,000 to $95,000
*depending on qualifications and experience level
Travel Required- Willingness to travel up to 10% overnight
QualificationsRequired Skills:- Bachelor's degree in science, nursing, or equivalent
- Working knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Familiarity with pharmaceutical and medical terminology
- Experience with management and oversight of eTMF
- Experience with EDC and TMF platforms
- Excellent interpersonal, verbal, and written communication skills
- Strong attention to detail and organizational skills
- Strong knowledge of MS Office Suite, Outlook and Gmail
Preferred Skills:- Risk-based monitoring (RBM) experience is a plus
- Working with trials conducted globally is a plus
Physical Demands & Work Environment:- Required to sit for prolonged periods of time
- While performing the duties of this job, the noise level in the work environment is usually quiet
The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements.
