The Clinical Trial Assistant II (CTA) is an essential part of the Local Study Team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, GCP, Pfizer SOPs and country regulations. The role collaborates with local study team members and is responsible for multiple tasks that span from study start-up to study close-out which enables the efficient execution of clinical trials to high quality standards.
- Works proactively and independently to coordinate and prioritize multiple key tasks at site, country and study level.
- Collaborates with local cross functional study team members of varying levels of seniority.
- Gathers and retains knowledge of local processes that enable clinical trial execution where required.
- Uses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards.
- Has fundamental knowledge of the principles and concepts related to the CTA role.
With general direction, the CTA is responsible for providing local operational support to Local Study Team members from study start up to close out.
CTAs may specialize in one or more routine tasks, and be expected to provide support across the whole role as needed.
Key tasks supported by the CTA group are :
- TMF filing, quality, maintenance, compliance, and oversight
- Lead the development and delivery of sites' ISF, and eISF when utilized, and act as primary point of contact for the sites and manage the Site Operations/monitor access to eISF prior to SIV
- Maintain Pfizer Registries and systems as required
- Support of site payment services, patient compensation services and other local payments as required
- Provide reporting to support management of clinical trials
- Provide support with audit and inspection readiness activities
- Perform customization of ICDs and other site documents and coordinate the translation of documents as required
- Manage Physical Archiving needs as required
- Preparation of documents and communications for distribution to and collection from sites, as required
- Provide support to CTA managers for development and implementation of on-boarding training for new hires:
- Mentor new hires and entry level CTAs
- Serve as SME for key CTA processes, systems and tasks.
- Work with CTA managers to identify continuous improvement opportunities to enhance operational efficiencies.
3 years relevant experience /strong understanding of the scope of clinical trial administration.
Experience in managing workload independently and manage priorities effectively
Experience in one or more of the follow: cross border logistics, registry system data management; TMF compliance; study team support role.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To apply please visit our website www.pfizercareers.com and search job id 4879099 for Clinical Trial Assistant (Sr) - II (CTA II)