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:
Project Support
- Requests payments in Ariba Category Management (ACM)/ Ariba for study related cost
- Updates the trial and site information as necessary in Corporate Clinical Trial Registry (CCTR) in a timely manner
- Attends appropriate training programs and project teleconferences as applicable
- Maintains the study status tracking and provides analysis report to Study Manager (SM)
- Assists SM on study budget control by timely tracking and reporting of actual cost and forecast drafting
- Coordinates Clinical Study Agreement approval to ensure site initiation on time
Study Start-Up
- Supports and coordinates the clinical trial application for amendment and progress report to ethics committee and regulatory authority, if applicable, and obtain approval within required timeline
- Coordinates and applies for export/ import license of, lab kits, equipment, and specimen, if applicable
- Supports for preparations of site initiation packages (e.g. Site Master File (SMF))
- Organizes investigator meeting
Study Conduct
- Supports and coordinates the clinical trial application for amendment and
progress report to ethics committee and regulatory authority, if applicable,and obtain approval within required timeline
- Maintains/ develops local tracking spreadsheets for study-related documents, data, tasks, and activities, as applicable
- Assists Clinical Research Associate (CRA) for the responsibility of tracking, distribution, and filling of clinical trial documents/ information (eg. Suspected and Unexpected Serious Adverse Reaction (SUSAR), paper Case Report Forms (CRFs), DCFs) with quality review for accuracy and completeness
Other responsibilities of the CTA
- Supports SMs/ CTA Lead for quality improve related initiatives
- Assists in preparation of newsletters and other study-related documents
- Complies with client Policies, SOPs & IGs and local regulations during various projects related transactions
- Takes Subject Matter Expert (SME) role and provides training to CRA/ SM regularly
- Ensures Metrics Compliance pertaining to CTA role
- Provides back-up coverage for other CTAs as necessary
- Mentors new CTA when applicable
- Supports CTA lead for production and tracking of trial metrics measurements
- Supports SM for coordinating with sites for finalizing budget worksheets and contractual agreements
- Maintains and ensures the availability of inventory for all non-drug supplies
- Provides logistic and administrative support to project teams
- Assists on SUSAR package preparation for Ethics Committee and regulatory authority, if applicable
Compliance with Parexel standards
- Complies with required training curriculum
- Completes timesheets accurately as required
- Submits expense reports as required
- Maintains a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
- Proficiency in basic Computer Literacy (e.g. Microsoft word, Excel and PowerPoint)
- Proficient in Chinese, good English skills in writing and reading
- Good interpersonal skills, good at communication
- A flexible attitude with respect to work assignments and new learning, quickly-learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Willingness to work in a matrix environment and to value the importance of teamwork
Knowledge and Experience:
- Knowledge of ICH GCP and local regulations is preferred
- Experience in clinical trial administration is preferred
- Experience in management of clinical trial and/ or regulatory documents is preferred
- Knowledge of application used in the clinical trials is preferred
Education:
- Science background is preferred
- High or secondary School diploma/ certificate or above, University Graduate is preferred