重庆招聘

Primary Duties (fundamental components of role-both strategic & operational):

Major Duties of CTA:

· Support the tasks below for assigned project throughout the study:

o Responsible for Trial Master File (TMF) maintenance in accordance with ICH-GCP and SOPs (ELARA scanning, indexing and QC within prescribed timelines)

o Updates the trial and site information as necessary in Corporate Clinical Trial Registry (CCTR) in a timely manner

o Attends appropriate training programs and project teleconferences as applicable.

o Maintains the study status tracking and provides analysis report to Study Manager.

o Assist Study Manager on study budget control by timely tracking and reporting of actual cost and forecast drafting.

o Coordinates Clinical Study Agreement approval to ensure site initiation on time.

· Study Start-Up

o Supports and coordinates the clinical trial application to ethics committee and regulatory authority, if applicable, to obtain approval within required timeline.

o Coordinates and applies for export/import license of, lab kits, equipments, and specimen, if applicable.

o Assists on the preparation, compilation, accuracy review and correction of Investigator Initiation Package (IIP) documents and obtaining approval(s) to ensure drug release in the defined timelines.

o Supports for preparation of site initiation packages (e.g. SMF)

o Organizes investigator meeting in country/regional base

o Assists Study Manager on TMF setup through communication with global study owner as necessary.

· Study Conduct

o 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.

o Ensures along with the CRA the reconciliation of Trial Master File and the Site Master File on a periodic basis.

o Maintains / develops local tracking spreadsheets for study-related documents, data, tasks and activities, as applicable.

o Assists CRA for the responsibility of tracking, distribution and filing of clinical trial documents/information (e.g. paper CRFs, DCFs ) with quality review for accuracy and completeness.

· Study Close-Out

o Ensures along with the CRA the reconciliation of Trial Master File and the Site Master File

o Supports SM and CRA for final archive of study-related documents

o Ensures study payment completion.

Other responsibilities of the CTA:

o Supports CQL for quality improve related initiatives

o Assists in preparation of newsletters and other study-related documents.

o Complies with Pfizer Policies, SOPs and local regulations during various projects related transactions

o Ensures P2L Compliance pertaining to CTA role.

o Provides back-up coverage for other CTAs as necessary.

o Supports SM for coordinating with sites for finalizing budget worksheets and contractual agreements (e.g. FCPA clauses).

o Maintains and ensures the availability of inventory for all non drug supplies.

o Provides logistic and administrative support to project teams.

o Assists on SUSAR package preparation for Ethics Committee and regulatory authority, if applicable

o Demonstrates and promotes Pfizer global value system across all interactions.

Training & Education

Required:

· College degree or above

· Good English skills in writing and reading (Above CET6)

· Proficiency in basic computer literacy (e.g. Microsoft word, Excel and PowerPoint)

2 years of clinical research experience

Preferred:

· Science Background

· University Graduate

· Experience in clinical trial administration

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