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Study Start Up and Regulatory Specialist

2022-09-29 15:44菲律宾1990
区域:Metro Manila (NCR)Mandaluyong
行业:Healthcare
职位:Practitioner / Medical Asst
部门:
人数:若干
性质:Full Time
性别:Male
婚姻:No marital status restrictions
学历:Open to all levels
经验:不限
年龄:18岁以上
待遇:₱ 33000-35000PHP/月

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
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