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Study Team Associate-FSPJob ID 80909BR China - Any Region - Home Based
Parexel FSP is currently seeking Clinical Trial Associate in Beijing / Shanghai, China
Working as a Clinical Trial Associate at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.
If impact, flexibility and career development appeal to you, Parexel FSP could be your next home.
Our Clinical Trial Associates work closely with the Project Leader and Functional Leads on project management tasks during the entire project lifecycle contributing to achievement of study deliverables.
Some Specifics About This Advertised Role
- Complete the delegated tasks under the guidance from STL.
- Expected to work on the tasks assigned in less complicated clinical trials independently.
- Lead the set-up of electronic Trial Master Files(eTMF)system Clinical Trial Management System.
- (CTMS). And keep the information updated during course of the study per requirement of the International Conference of Harmonization Guidelines for Good Clinical Practice(ICH/GCP)and SOP.
- Create and maintain the communication platforms (MS Team, SPOL Group email list etc.,) for the whole study team.
- Control the access of systems deployed to a specific study, include but not limited to IxRED, CTMS and eTMF.
- Support clinical trial registration and disclosure on public portal according to the requirement of regulatory authorities.
- Involved in the submission package preparation (including HGR Submission) by working closely with STL CRAs and functional stakeholders.
- Contribute to the clinical trial documents development such as study protocol, ICF, study results report and management plan per STL assignment.
- Responsible for overall TMF library healthy status. Guide study team members (functionals and CRAs) on the eTMF/paper TMF documents transfer & archival and lead Quality Check (QC) per TMF Plan..
- Contribute to the finance related activities such as contract sign-off I&PO set-up, invoice process budget tracker maintenance and reconciliation, including sites and third-party vendors.
- Support goods purchase, document delivery, devices shipment and recycle during the conduct of clinical trial.
- Coordinate and arrange the internal and external meetings, include but not limited to study team meetings vendor defense meetings, investigator meetings committee review meetings. And take meeting minutes/record if necessary.
- Compile and maintain the clinical trial related lists and logs, include but not limited to study document.
- version tracker decision &issue &risk log, study contact list Q&A log, vendor & system list, study specific training log.
- Draft and distribute the newsletters/communication letters/presentation materials to internal and externa stakeholders.
- Complete delegated tasks during the audit and inspection by regulatory authorities.
QualificationsHere are a few requirements specific to this role:
- Educational Background Bachelor’s degree or above (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution
- Working Experiences and Competencies
- Proven organizational and presentation skills
- Ability to manage multiple tasks and meticulous attention to detail
- Quick learner, good team player
- 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
- Good knowledge of ICH-GCP, 1-year Experience as CTA, CRC, or other roles in the clinical trials is preferable
Not quite the CTA role for you?
Don’t worry we need CTAs for different locations, sponsors, and therapeutic areas, and at entry, mid and senior levels.
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