Senior Clinical Research Associate

Basic qualifications:

  1. Able to complete complicated tasks independently, not necessarily requiring close supervision,

able to perform study specific task

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

  2. Familiarity with Good Clinical Practice and relevant local regulations

  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

  1. At least 1 year monitoring experience in the top pharmaceutical or CRO

Preferred qualifications:

N/A

Details:

Responsible for monitoring of all types of clinical studies with a certain degree of independence

Ensures clinical studies are conducted in accordance with protocol, SOP/guidance, GCP and local regulations

Develop and maintain excellent working relationships with external and internal customers to ensure the smooth ongoing and timely delivery of clinical studies

If need, Perform other tasks assigned by line manager

As required, assist the study manager with particular tasks

Prepare, conduct and report on pre-study visits; Identify potential investigators and check Site

staff/facility qualifications

Prepare, conduct and report on Site Initiation visits; Ensure investigator has submitted regulatory

documents to IEC as required; Co-ordinate shipment and review storage/dispensing of IP and other study related materials

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

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

verifies investigational product management; ensures AEs and SAEs have been reported as per the protocol, performs other relevant monitoring tasks and resolves queries; Maintain regular telephone contact with investigators 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; Ensure regulatory documents available and updated; Ensure IP and

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

report submission to EC; Ensure final payment processed to investigators

Attend inv meeting and ensure inv to join the meeting; prepare and deliver the presentation in inv

meeting; conduct site and prepare the meeting materials

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

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

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

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

regulations at Investigator sites and Sponsor site; Ensure they are complete and correct

Responsible to set site recruitment plan and deliver patients to the plans (actual versus planned)

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

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

SOP/guidance/regulations training and reading; Share and drive best practice with team members;

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

Perform study specific tasks assigned by study manager

  • LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

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