Milestone Technologies, Inc.
Clinical Trial Associate (Foster City)
Milestone Technologies, Inc., Foster City, California, United States, 94420
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.
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.