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Job Descriptions

Clinical Trial Management Assistant, Level 1

Position Summary

CRC Oncology is seeking for a Clinical Trial Management Assistant who will be responsible to report to the Clinical Trial Manager or Senior Clinical Trial Manager and will function as an in-house team member supporting the conduct of clinical trials and the handling of the administrative aspects of clinical trial execution. This role will drive completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required.

Responsibilities

• Coordinate and assist with trial start-up activities, including budget and contract negotiations, ICF revisions, and essential document packages
• Coordinates and tracks study documentation and other functional activities that relate to the conduct of clinical trials
• Tracks metrics and study start-up timelines to identify trends and opportunities for improvement
• Track and report on study progress including site activation, patient enrollment, monitoring visits
• Ensures that all essential study documents are filed appropriately and kept in an organized central repository for the project team
• Reviews Site Visit Reports for accuracy, quality, and consistency
• Leads the management of the TMF, including establishing QC processes and reconciliation of findings
• Assists with protocol and study-specific training with vendors, site personnel, and clinical sites
• Supports Clinical Trial Managers with vendor management activities

Qualifications

• MS preferred, open to hire entry level and newly graduated candidates
• Must be bilingual (Fluent in English and Chinese)
• Professional, proactive demeanor
• Strong interpersonal skills
• Excellent written and verbal communication skills
• Experience with people management and development of staff
• Excellent interpersonal and project management skills
• Comprehensive knowledge of clinical trials methodology (experience with Bayesian methods preferred), regulatory requirements, and statistical software packages. Experience with interventional, observational and retrospective studies. Ability to contribute strategically.
• Able to collaborate effectively with internal and external study management teams to meet project timelines
• Must be solution-oriented and willing to educate study team members in appropriate interpretation of designs and results

Employment Type

Full-time