Senior Clinical Research Associate

This is a fully remote position, open to applicants in Taiwan.

📋 Description

• The Clinical Research Associate (CRA) offers comprehensive support to clinical project teams and study sites involved in clinical research initiatives.

• Manages all facets of study site operations to ensure patient safety is prioritized, the quality of data produced by managed sites remains high, resulting in consistently low query rates and satisfactory Quality Assurance reports.

• Provides direction at both the site and project levels regarding audit readiness standards and aids in the preparation for audits and necessary follow-up actions.

• Updates, monitors, and maintains trial-specific management tools/systems and status reports.

• If needed, oversees site startup processes, including assessing feasibility and recruiting potential investigators, preparing EC/IRB submissions, and collecting and reviewing regulatory documents.

• If necessary, assists in negotiating study budgets and executing investigator contracts under the guidance of the Site Contract Management department or its designee.

• Independently performs all types of site visits, including pre-study qualification, initiation, routine monitoring, and close-out visits, in compliance with the protocol, local regulations, ICH-GCP, and Precision's Standard Operating Procedures (SOPs).

• Documents activities through confirmation letters, follow-up letters, trip reports, communication logs, and other essential project documents in accordance with SOPs.

• Effectively and proactively communicates with site personnel and the Precision Project and Clinical Trial Management teams to address protocol/study concerns, including any deviations, and implements required actions in response.

• Cultivates and maintains positive relationships with investigators and study staff, acting as an ambassador to uphold Precision's high standards and professional image.

⛳️ Requirements

• Bachelor's degree or international equivalent, or a combination of education and experience, ideally in a business, scientific, or healthcare field.

• A minimum of 2 years of on-site monitoring experience for CRAII; 1 year of oncology and Phase I experience is preferred.

• High proficiency in the Microsoft Office suite (Outlook, Word, Excel, and PowerPoint).

• Strong customer service orientation; demonstrates flexibility and a collaborative spirit.

• Ability to maintain focus on detail for extended periods, with a strong emphasis on accuracy.

• Proficient in English communication, both spoken and written.

• Familiarity with the drug development process.

🏝️ Benefits

• Health insurance

• Flexible working arrangements

• Professional development opportunities