Job Details

Sr. Clinical Trial Associate

W2 (ONLY - no c2c or sponsorship) contract

Hybrid (requires two days on-site) in Foster City, CA

Target Pay - 45-50 hourly - W2 (40 hours)

1 year duration

Bay Area Only candidates will be considered

• Must have at least 5 years of recent Clinical Trials Associate (CTA) experience
• US study experience for therapeutics is required.
• Basic knowledge of clinical trial processes and ICH/GCP guidelines, eTMF management and DIA TMF Reference Model.

Sr. Clinical Trial Associate

Assist the study lead by coordinating various administrative aspects of the project management and oversight activities. Support the study lead with study start-up activities, tracking study progress, overseeing the trial master file quality and completeness, maintaining meeting agendas and minutes, and implementing learnings/sharing knowledge with other study management teams within Mirum.

JOB FUNCTIONS/ RESPONSIBILITIES

To support the Study Management Teams with the following:

• Study start-up activities.
• Site and vendor management.
• Writing and distributing meeting agendas and meeting minutes.
• Organizing and planning of meetings (e.g. agendas, minutes, rooms, participants).
• Creating and managing trackers and logs for oversight of clinical trials.
• Ensuring a high-quality filing structure and archiving of trial documents.
• Oversight, maintenance and regular checks of trial master file.

QUALIFICATIONS

Education/Experience:

• Masters Degree in Science highly preferred
• Bachelor's Degree in Science required (if no master's)
• 4 years of experience from a CTA position.
• Strong organization skills.
• Assist with creation and maintenance of study metrics trackers, tools and reports.
• Experience working with Trial Master Files and performing periodic review of study files for accuracy and completeness.

Knowledge, Skills and Abilities:

• Basic knowledge of clinical trial processes and ICH/GCP guidelines, eTMF management and DIA TMF Reference Model.
• Assist in review of study specific documents, including plans, IRB submissions, patient documents and study tools.
• Proficient in the use of Microsoft Office.
• Well-organized with excellent time management skills.
• Good written and verbal communication skills.
• Experience working effectively in a fast-paced environment.