Clinical Trial Assistant

About the role

The Clinical Trial Assistant is a member of the clinical trial team supporting delivery of clinical studies within the sponsor. The CTA will support the study team to ensure the operational deliveries are executed on the expected timeline, approved budget, and at high quality from protocol development through study setup, maintenance, close out, and study archiving.

The CTA supports the study team in delegated activities and provides technical, administrative, and logistical support to ensure efficient execution of clinical trials in line with ICH/GCP, sponsor SOPs, and regulatory regulations.

Responsibilities

• Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOPs.
• Create and maintain communication platforms (i.e., MS Teams, SPOL, group email list) for the study team.
• Control systems access for assigned studies, including but not limited to IxRS, EDC, CTMS, and eTMF.
• Support clinical trial registration and disclosure on websites per applicable regulatory requirements.
• Responsible for overall TMF status. Guide study team members on the eTMF/paper TMF document transfer and archival. Lead the quality check (QC) per the TMF plan. Help draft TMF plan.
• Facilitate finance-related activities such as sign-off, IO and PO setup, processing invoices, tracking accruals, and budget maintenance and reconciliation for sites and third-party vendors.
• Support oversight of monitoring visit report review. Activities include updating MVR trackers and overseeing MVR review metrics.
• May support data oversight and reconciliation efforts in vendor systems, SAEs, protocol deviations, and more as needed per study.
• Coordinate and track clinical supplies.
• Coordinate and arrange internal and external meetings, including but not limited to study team meetings, vendor defense meetings, investigator meetings, and committee review meetings; take meeting minutes as needed.
• Compile and maintain clinical trial-related lists and logs, including but not limited to study document version tracker, decision risk log, contact list, Q&A log, vendor list, and specific training log.
• Draft and distribute newsletters, communications, and Asia materials to internal and external stakeholders.
• Complete delegated tasks during audit and inspection by regulatory authorities.

Requirements

• High school or GED with four years of relevant experience.
• Bachelor’s degree or above (Life Sciences preferred) or certification in a related health profession (i.e., nursing, medical, or laboratory technology) from an accredited institution is preferred.
• At least 1 year of experience as a CTA, CRC, or other role in clinical trials.
• Oncology experience is a plus.
• Proven organizational and presentation skills.
• Ability to manage multiple tasks with meticulous attention to detail.
• Quick learner and team player.
• Excellent written and verbal communication skills.
• Computer proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
• Good knowledge of ICH/GCP.

Schedule

Position is on-site 3-4 days a week at the client office in South San Francisco, CA, and remote the remaining days.

Pay

Salary range: $56,704.00 - $70,880.00. You may be eligible for a bonus, stock compensation, and commissions depending on your role and performance.

Benefits

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals for well-being support.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.