Study Start Up and Regulatory Specialist

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 packagePaid leavesHMO coverage with dependentAccidental / life insurance15% Night differential