Study Start Up and Regulatory Specialist
Jobs and Careers at SSG

Study Start Up and Regulatory Specialist

SSG
Local
1 month ago
Local
Jobs and Careers at SSG
SSG is hiring a
Posted 1 month ago
Apply before October 13, 2022

Job Description

Job description

·    Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures

·        Adhere to monitoring plan protocols; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates

·        Monitor clinical trial progress through a combination of data review and on site monitoring visits

·        Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification/review)

·        Independently coordinate ongoing and upcoming monitoring assignments

·        Knowledgeable in ICH guidelines, GCP, and clinical trial study process

·        Ability to work effectively in teams as well as independently.

·        Ability to manage multiple projects at a time.

·        Meet expected timelines for completion of monitoring activities and submission of written monitoring reports

Qualifications

·        Must be a graduate of any medical allied course

·        At least 1 year prior experience in clinical research

·        Good communication skills – both written and oral

·        Willing to work on shifting schedule,holidays, and weekends

·        Willing to work onsite – Mandaluyong site

·        Candidates with updated NBI and PSA Birth Certificate are highly prioritized!

Benefits

  • Php 33, 000.00 to Php 35, 000.00 salary package
  • Paid leaves
  • HMO coverage with dependent
  • Accidental / life insurance
  • 15% Night differential

How do you apply?

To learn more and apply, visit us at link or click the Apply Now Button below.

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