Contract to Perm Clinical Trial Research Asosciate - Onco/ Respiratory MNC

Recruit Express Pte Ltd| Date Posted: 27-Jun-2020
EA Licence No: 99C4599|EA Personal Registration No: R1875164
Save Job
Job Nature:
Permanent, Contract
Position Level:
Entry Level, Experienced
Qualification:
Bachelor's / Honours

Job Description


Responsibilities and Duties

  • Responsible for preparing, organizing, managing and monitoring clinical trials in accordance with the highest standards
  • Responsible for performing all monitoring aspects of clinical trials as stated in ICH E6 GCP/applicable local SOP/GCPs to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements
  • Perform site selection, initiation, monitoring an close-out visits in accordance with sponsor's and/or company's standard operating procedures (SOPs) and study requirements
  • Develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents
  • Develop, compile and/or submit dossiers to regulatory and/or ethics committee for review and follow up until approval, if required, including translation and review of translations (as applicable)
  • Support in safety reporting to regulatory and/or ethics committee as required, including translation and review of translations (as applicable)
  • Support in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required
  • Support/assist in feasibility studies, site and investigator identification as required
  • Support/Assist in Site and CRO audit or inspection as required
  • Assist to set up, review and maintain project files to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements
  • Support Company's operations by assisting/coordinating and conducting orientation and applicable training for new employees as required
  • Review, revise and/or develop Clinical Monitoring related SOPs, work guides etc.

 

Requirement

  • Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience
  • Minimum 1-2 years  relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry 
  • Good knowledge of medical terminology and clinical/medical practices
  • Preferably has experience in clinical study monitoring
  • Good understanding of cross-functional processes, clinical trial processes and regulatory environment
  • Possess advanced monitoring skills and clinical trial management
  • Certificate in basic and advanced GCP course

 

Interested candidates please submit your resume to [Click Here to Email Your Resume]

 

Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)

Company Overview
Recruit Express Pte Ltd