Clinical Trial Associate Job Summary
The Clinical Trial Assistant (CTA) performs essential responsibilities for successful trial execution at the client. The CTA assists with the coordination of activities associated with the start-up, management, and close-out of clinical studies under the direction the Clinical Operations team. This may include assisting with study matters that impact study timelines, quality and budget. Job Responsibilities
The Clinical Trial Assistant can be partly or fully responsible for the following areas depending on his/her level of proficiency. Responsibilities may include, but are not limited to:
- Create/maintain essential document trackers
- Conduct comprehensive review, as per Trial Master File (TMF) Plan
- Provide continuous input to electronic Trial Master File (eTMF) content list
- Assist with Clinical Operations internal filing of study documents
Contracts & Budgets:
- Facilitate the initiation and maintenance of the Clinical Trial Agreements, contract execution, vendor purchase orders
Clinical Operations Managed Vendors & CRO:
- Reconciliation & management of key documents (plans, site contact list, etc.)
- Assist in any purchase order (PO) related inquiries
- Ensure vendor PO contains funds for insurance and translation vendors
Study Start Up:
- Provide administrative assistance with internal and external meetings including investigator meeting(s)
- Request and distribute insurance policy/certificates (see Insurance section)
- Assisting in the management of CRO deliverables (from meeting minutes to finalized ICF)
- Ensure accurate study entry and updates to ClinicalTrials.gov
Study Conduct and Close-out:
Education & Qualifications
- Ensure MVR tracking and filing of sponsor comments
- Identify issues, with potential resolution, and escalate when appropriate
- Assist in the conduct of study close-out activities (sites, reconciliation activities, filing & archiving)
- Track and collate clinical trial documentation related to CSR appendices
- The Clinical Trial Assistant is also assisting in insurance and investigational product related activities
- BA/BS or higher in nursing, life or health sciences is preferred.
- Industry or relevant experience in lieu of education is considered.
- 1 year pharmaceutical industry experience
- The Clinical Trial Assistant is expected to be in the process of developing foundational competence in critical areas required for long term success in Clinical Operations across Communication and Collaboration, Proactivity and Adaptability, Analysis, Problem solving and Decision Making.
- Responds promptly with clear, organized written and oral communication
- Takes ownership and accountability for completing assigned tasks and perseveres through obstacles
- Embraces new challenges or changed priorities and adjusts plans and priorities accordingly
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.