Clinical Trial Associate - San Diego, CA

Mirador Therapeutics, Inc.•San Diego, CA

34d•$85,000 - $105,000•Onsite

About The Position

Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company’s Mirador360 TM precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA. Summary The Clinical Trial Associate will work with the Global Clinical Trial lead and other members of Clinical Development/Clinical Operations to coordinate the start-up, execution, and closeout of clinical trials. This individual will also perform administrative responsibilities within the functional team as needed.

Requirements

Bachelor’s degree in a health-related field.
2 or more years experience working in clinical research; biotech or pharmaceutical industry preferred.
Knowledge and experience in overseeing and/or maintaining a TMF.
Good understanding of principles of good clinical practice.
Demonstrated knowledge and experience with relevant IRT, EDC and other third-party systems.
Demonstrated agility to learn, and prioritize multiple responsibilities independently, remove barriers and drive projects to completion.
Strong oral and written communications skills.
Ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team.
Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships.
Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems; ability to work with large databases.

Responsibilities

Develops and maintains study oversight tools including trackers, spreadsheets, and filing systems for various studies.
Creates, maintains, and tracks information for keys study activities and needs (e.g., study contact list, site start-up, enrolment, histological slides, etc.).
Meeting coordination and preparation activities; agendas, take, finalize, and file meeting minutes as needed.
Works with the Global Clinical Trial lead on Site Qualification and Site Selection Activities.
Oversees the preparation, review, distribution and follow-up with investigative sites for essential documents.
Contributes to the development of study-related documents and tools.
Oversees the ordering, distribution and tracking of trial materials, e.g., eDiaries, lab supplies.
Provides oversight of regulatory documents required for Local/Central IRB Submissions, EC Submissions, through investigational product greenlight/ release to ensure completeness and quality.
Reviews regulatory documents to support site updates to the IND.
Ensures TMF Inspection readiness:
Works with the Global Clinical Trial lead on creation of TMF Index and TMF Plan.
Conducts periodic TMF document content review for completeness.
Ensures documents are filed in the correct locations and file naming conventions are correct.
Assists with quality reviews of TMF.
Assist in the archiving of study documentation for the TMF.
Tracking milestones, generating study metrics, and providing written and verbal updates to management.
Liaises with the study team and/or others to resolve study related discrepancies and issues.
Ensures adherence to pertinent regulatory requirements and to departmental polices, practices and procedures. Ensures knowledge is kept up to date by reading SOP's and maintaining awareness of GCP guidelines.
May participate in the development of SOPs, Work Practices and Work Instructions.
Additional duties assigned as needed.