Senior Clinical Research Associate

Precision Medicine Group

Clinical Research Associate providing support to clinical research studies focusing on Oncology and Rare Disease. Ensuring data quality and adherence to regulatory guidelines while working in a remote environment.

Posted 5/4/2026full-timeRemote • 🇹🇼 TaiwanSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

The CRA provides overall support to study sites and clinical project teams engaged in clinical research studies.
Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Updates, tracks and maintains study specific trial management tools/systems, and status reports.
If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents.
If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs.
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs.
Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.

Requirements

What you’ll need

Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
Minimum of 2 years of on-site monitoring experience for CRAII; 1 year oncology and Phase I experience preferred.
High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
Customer service demeanour; demonstrate flexibility and teamwork.
Ability to focus on detail for extended periods of time, high attention to accuracy.
Fluency in English communication, verbally and in writing.
Working knowledge of the drug development process.

Benefits

Comp & perks

Health insurance
Flexible working arrangements
Professional development opportunities

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

on-site monitoringaudit readinessregulatory document reviewstudy budget negotiationinvestigator contract executionclinical researchdata quality assuranceprotocol complianceICH-GCPdrug development process

Soft Skills

customer serviceflexibilityteamworkattention to detailaccuracyeffective communicationrelationship buildingproactive problem solvingprofessionalismambassadorship