Clinical Trial Assistant
This is a fully remote, contract position based in South San Francisco, CA, with a preference for candidates who can work Pacific Standard Time (PST) hours. There is an option to work on-site once a week in South San Francisco. The role offers the potential to convert to a permanent position after 1–2 years on contract.
About the role
As a Clinical Trial Assistant, you will support a single molecule across multiple clinical programs, managing trial coordination and administrative tasks. This role is crucial in ensuring efficient study execution through organization, document control, and operational tracking. You will provide foundational support for Clinical Trial Management Systems (CTMS) data that is in place but not yet fully utilized.
Responsibilities
- Support multiple studies/programs for a single molecule under the direction of Clinical Trial Managers (CTMs) or Directors.
- Manage day-to-day study coordination activities that do not require senior oversight.
- Maintain study trackers for milestones, timelines, deliverables, and action items.
- Support follow-up on assigned tasks with internal teams, Contract Research Organizations (CROs), and vendors.
- Provide data entry, updates, and quality checks in the CTMS.
- Assist with the population and ongoing maintenance of CTMS data as utilization increases.
- Identify and flag inconsistencies or gaps to CTMs.
- Prepare and distribute agendas, minutes, and action logs for study meetings.
- Assist with preparation, formatting, and review of study documents and communications.
- Communicate with CROs and vendors as directed.
- Escalate operational issues or risks appropriately to CTMs.
Requirements
- Understanding of the clinical trial lifecycle and supporting multiple studies concurrently.
- Familiarity with clinical systems such as CTMS and document repositories.
- Strong attention to detail, organization, and follow-through.
- Ability to take ownership as needed and work effectively in an environment with developing processes and infrastructure.
- Prior sponsor-side CTA or Clinical Research Associate (CRA) experience.
- Strong time management and prioritization skills, especially when handling multiple urgent tasks.
- Strong TMF (Trial Master File) filing, TMF quality control, and inspection readiness experience.
- Deep understanding of document quality review, including dates and signatures.
- Ability to verify all versions of required documents.
Qualifications
- Experience in on-site co-monitoring visits or relevant monitoring experience is a plus.
- Demonstrates problem-solving skills and critical thinking about quality and compliance.
- Confidence in speaking about their experience and expertise.
Benefits
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental, and vision
- Critical Illness, Accident, and Hospital coverage
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short- and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- 6 paid holidays and 1 week of accrued PTO per year
Pay
$50.00 - $60.00/hour
Schedule
- Fully remote with optional on-site work once a week in South San Francisco, CA.
- 12-month contract with the possibility of extension based on business needs and performance.