Bayside Solutions ยท 2 weeks ago
Clinical Trial Assistant
San Mateo County, CA
Contract
Hybrid
New Grad, Entry Level
$94K/yr - $114K/yr
0+ years expBayside Solutions is seeking an entry-level Clinical Trial Assistant to provide administrative and operational support for clinical studies. The role involves executing well-defined tasks that support the startup, maintenance, and close-out of clinical studies under the supervision of the Clinical Program Manager.
Information TechnologyStaffing AgencyTelecommunicationsVirtual Reality
No H1B
Responsibilities
Work on assignments and problems of limited scope, requiring independent decision-making and initiative, using standard procedures under close supervision
Solicit Clinical Study Execution Team (CSET) meeting agenda topics, coordinate meetings, minutes, and logistical support
Liaise with internal teams and vendors for document collection and updates; act as primary CTA contact on studies
File study documents to the Trial Master File (TMF) and assist with TMF reviews. Maintain TMF and ensure document quality and completeness
Create, maintain, and manage TMF Study Plans and ensure filing compliance across internal and vendor teams
Collaborate with vendors to support ongoing TMF and operational deliverables, ensuring consistency across all study documentation
Maintain study training matrices and submit finalized records to ComplianceWire to ensure ongoing inspection readiness
Maintain study trackers, including but not limited to CSET Team Member lists, Master Study Metrics Tracker, Vendor Contact List, and other key operational trackers to support cross-functional visibility
Support development and maintenance of RCR (Regulatory Compliance Review) packs for Phase I Healthy Volunteer studies to ensure completeness and readiness for sponsor and regulatory review
May assist with protocol amendment documentation and version control
May assist with the development of basic department initiatives, process documents, and standard forms most used by CTAs
Support other clinical operations activities as appropriate
Qualification
Required
BS, BA, or RN in a relevant scientific discipline
0-3 years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience
Familiar with Phase I Healthy Volunteer studies, including study startup, document management, and coordination of cross-functional deliverables
Basic understanding of FDA and EMA Regulations, ICH guidelines, GCP, and familiarity with standard clinical operation procedures (SOPs)
Basic organization and communication skills
Proficient in MS Office (Word, Excel, Outlook) and project tracking tools
Demonstrate reliability, proactive communication, and quality in task execution
Apply knowledge of Clinical Operations in day-to-day assigned tasks
Thrive in a collaborative team setting and be driven by a desire to deploy innovative approaches and technologies in a high-energy environment
Travel may be required (~10%)
Preferred
Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS, SmartSheet)
Oncology & Phase 1 Healthy Volunteer Study experience preferred
Company
Bayside Solutions
Bayside Solutions is a staffing and recruiting company offering IT, telecom, and scientific staffing services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
B
Bob Klotz
Founder
Company data provided by crunchbase