Study Start Up and Regulatory Specialist

Industry Category	Healthcare	Position	Practitioner / Medical Asst
Recruitment Department		Number Of Recruits	several
Work Location	Metro Manila (NCR) Mandaluyong	Nature Of Work	Full Time
Gender Requirements	Male	Marriage Requirement	No marital status restrictions
Education Level	Open to all levels	Work Experience	No work experience restrictions
Age Requirement	Above 18 years old	Salary Package	33000-35000 PHP / Monthly
Updated Date	2022-09-29	Valid Until	Long-term validity

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