Respoible for monitoring of all types of clinical studies under supervision of study manager

？ Eures clinical studies are conducted in accordance with protocol, SOP/guidance, GCP and local

regulatio

？ Develop and maintain excellent working relatiohips with external and internal custome to eure

the smooth ongoing and timely delivery of clinical studies

？ If need, Perform other tasks assigned by line manager

？ Prepare, conduct and report on pre-study visits under the supervision of study manager; Assist in

potential investigator identification, check Site staff/facility qualificatio

？ Prepare, conduct and report on Site Initiation visits under the supervision of study manager; Eure

investigator has submitted regulatory documents to IEC as required; Co-ordinate shipment and

review storage/dispeing of IP and other study related materials

？ Prepare, conduct and report on Site Monitoring visits; Performs source data verification and CRF

review, verifies informed coent form completion, IEC filing documents and subject eligibility,

verifies investigational product management; eures AEs and SAEs have been reported as per the

protocol, performs other relevant monitoring tasks and resolves queries; Maintain regular telephone

contact with investigato and written correspondence with site; Track investigator payment Prepare for, conduct and report on Study Closure visit; Retrieve CRFs if applicable; Resolve

outstanding queries and issues; Eure regulatory documents available and updated; Eure IP and

study material accounted, returned and destroyed if required; Eure site closure summary and study

report submission to EC; Eure final payment processed to investigato

？ Attend inv meeting and eure inv to join the meeting; Conduct and prepare site meeting materials

under the supervision of study manager

Evaluates the quality and integrity of study sites performance; Verifies the continuing compliance of

the site with applicable regulatory and ethical requirements and the protocol/amendments; Reports

07 Dec 2011

relevant activities and findings in MVR and follow-up letter, escalates study-related issues to internal

stakeholder and PI and investigato, and proactively follows them up until resolution

？ Obtain and maintain essential documentation in compliance with ICH GCP, SOPs and local

regulatio at Investigator sites and Spoor site; Eure they are complete and correct

？ Respoible to set site recruitment plan and deliver patients to the pla (actual veus planned)

？ Updates and maintai clinical metrics data via clinical study tracking tools such as eTrack

Complete and pass new starter assessment and programme; Complete all required

SOP/guidance/regulatio training and reading; Share and drive best practice with team membe;

Attend and actively contribute to meetings and trainings

？ Prepare for, participate, respond and follow up to Clinical Quality Audit, QC and co-monitoring

findings at investigator sites. Prepare and implement an action plan to improve compliance if needed

？ Perform other tasks assigned by line manager

Basic Requirements:

Must be non-comparative, objective and relevant. Critical/essential to accomplish the role

1. May need supervision and appropriate support from line manager and study manager or

experienced staff to fufill complicated tasks

Preferred Requirements:

1. Bachelo degree in clinical medicine or a life/biological science

2. Familiarity with Good Clinical Practice and relevant local regulatio

3. Good command of spoken and written English and able to read it accurately

4. Good computer skills including proficiency with Microsoft Word, Explorer and Outlook and

familiarity with the internet

5. Less than 3 year monitoring experience