Job Posting

招 聘 通 知

There is one open position of Clinical Trial Assistant in Medical Department, based in Beijing, reporting to the Clinical Operations Manager, Ms. Zhang Xiaotian. Please refer to the job description as below:

Position:   Clinical Trial Assistant

Reporting to:   Clinical Operations Manager

Working Location:  Beijing

JOB SUMMARY

The Clinical Trial Assistant (CTA) provides full support in clinical trial documents management to study teams during the preparation, conduction and close-out of clinical trials. This includes scanning, uploading essential documents into Electronic Library and Records Archive (ELARA), conducing Index QC, scanning Case Report Forms (CRFs), Trial Master File (TMF) Library Management, and other tasks as assigned by the Clinical Operations Manager (COM). 

The CTA may also work together with study team on planning and organizing investigator meetings. Currently several tracking systems are being used during the clinical trial conduction. The CTA may support study teams in system management under the instruction of COM.

The CTA is an in-house position and reports to the Clinical Operations Manager (COM). She/he must be able to work independently, as well as in a collaborative team setting, on assigned responsibilities.

KEY RESULT AREAS & JOB ACTIVITIES/TASKS

1.   Clinical Trial Documents Management

-  Set up and maintenance of trial master files-electronic and/or paper

-  Process clinical trial documents, including scanning, image QC, uploading documents to ELARA and conducting Index QC where necessary

-  Scan Case Report Form (CRF) pages to Data Center

-  Assist Clinical Research Associates (CRAs) in setting up investigator Site Master File (SMF)

-  Assist COM in clinical trial documents management metrics report

-  Be creative and bring forward new ideas to help COM improve local working procedures in China

2.      Trial Master File (TMF) Library Management

Perform below TMF Library Management tasks as assigned by COM:

-  Manage transfer packs, handle closed packs (Elara Studies) and archive the envelops in the TMF Library

-  Perform administrative check of the air temperature and humidity of the TMF Library at regular intervals as instructed

-  Coordinate with Human Resource department and company security to prevent fire and infestation by insects or vermin

-  Keep a master inventory list of the trial binders and envelopes, and conduct a final check twice a year

-  Assist QSPIM in the trial documents off-site long term archiving 

-  Keep a record of all processes and controls

3.      Meetings/Training Planning and Support

Perform below tasks as assigned by COM:

-  Assist project leaders to well plan investigator’s meeting and training

-  Contact with travel agencies for activity arrangement and cost negotiation

-  Coordinate flight tickets and accommodation for both investigators and clinical research staff

-  Coordinate with foreign visitor on their travel/visit requirements and organizes travel arrangements and hotel accommodation

-  Coordinate meeting materials printing and dispatching

-  Arrange meeting facilities

-  Assist Clinical Research Managers (CRMs)/COM to plan and arrange group meetings and trainings when necessary

4.      Other Support to Study Team

Perform below tasks as assigned by COM:

-  Assist study team in assembling, maintaining and shipment of non-drug supplies required at clinical investigative sites

-  Enter data into RighTrack II and maintain the record

-  Assist study team in contract payment and budget tracking

-  Make arrangement to coming and outgoing mail and courier

-  Maintain work-related files

-  Circulate and file reading materials

-  Ensure proper and sufficient stationery for projects assigned

-  Answer and take down messages when Clinical Research staff is away

-  Fast and accurate verification of Clinical Research staff expenses claims ensuring timely submission for approval

-  Design forms and prepare reports if needed 

5.      Clinical Supply Management

Perform below tasks as assigned by COM:

-  Double check the study drug together with CSC prior to drug shipment to site for IMPALA studies

-  Work as the back up of Clinical Supply Coordinator (CSC) when CSC is not available

BACKGROUND REQUIREMENTS

1.    Education

-  College Degree or above

-  Medical, or Pharmacy, or other life science education background preferred

2.    Working Experiences

-  Prefer to have had experience in assisting with clinical trial and regulatory filings documents

-  Preferably at least 1 year experience as a clinical trial assistant or secretary

-  Understanding of medical and clinical trial documents terms

-  Proficiency in Basic Microsoft Word, PowerPoint and Excel

-  Familiar with use of databases, knowledge of Access is a plus

-  Good English skills in speaking, reading, and writing

COMPETENCIES REQUIREMENTS

1.    Functional Ability

-  Detail and quality oriented

-  Initiative

-  Teamwork/Collaboration

-  Judgment, problem assessment and problem solving skills

-  Customer service orientation

-  Good in planning and organization

-  Organizational awareness

-  Maximizing performance

2.    Cultural Competencies (Leader Behaviors)

-  Sustain Focus on Performance

-  Align Across Pfizer

-  Embrace Change

-  Encourage Open Discussion and Debate

-  Create an Inclusive Environment

Human Resources Department