Clinical Trial Associate (FSP) - Wuhan

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

Study Team Supporting

• TMF: Set up and maintain the site level TF/eTMF, coordinate on document collection, uploading into SharePoint (SP)/eTMF, check the document completeness, and provide TMF/eTMF quality control (QC) if required.
• EC Submission: Coordinate on EC submission dossier, site start-up preparation, and EC fee application and tracking.
• Process protocol amendments; may include IF updates.
• Tracker/Metrics Report: Collect and update study trackers/metrics report for site level if needed.
• Site Contract and Payment: Assist in contract signature process; assist in site level payment initiative and payment and invoice tracking.
• Site Materials and Equipment: Distribute site materials and equipment, document printing, shipment, and other administrative work.
• Administrative: Business and department office administration support if required.
• To undertake other reasonably related duties as may be assigned from time to time, as appropriate for level of experience.

Compliance with Parexel standards

• Comply with required training curriculum.
• Complete timesheets accurately as required.
• Submit expense reports as required.
• Update CV as required.
• Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• Proven organizational and presentation skills.
• Ability to manage multiple tasks and meticulous attention to detail.
• Agile & quick learner, good team player
• Willingness and ability to train others on study administration procedures.
• Excellent written and verbal communication skills.
• Good written and spoken English.
• Computer Proficiency: ability to handle daily work via Microsoft Word, Excel, PowerPoint, and Outlook, etc.

Knowledge and Experience:

• 0.5 years of clinical trial experience in the pharmaceutical of CRO industry. Exceptions may be considered based on level of training and mentoring available.
• Read, write, and speak fluent English; fluent in host country language may be required.
• Excellent organizational skills and ability to prioritize and multitask.
• 2 or more years of clinical trial experience in the pharmaceutical or CRO industry.

Education:

• Bachelor's degree or above in life sciences, English, and management.

Originally posted on Himalayas