Regulatory specialist (wfh)One CoreDev IT

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Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations,
Adhere to monitoring plan protocols, e.g., monitoring visit type, frequency, and required
Monitor clinical trial progress through a combination of data review and on-site monitoring
Verify that trial data is consistent with patient clinical notes and other source
QC daily visits and creates queries within the CRIO system and sponsor portals (EDC).
Send weekly unresolved query reports to the site manager.
Entering data within EMR system and the sponsors EDC portal
Ability to track and maintain monitor visits.
Review all sponsors follow up letters with the study's Lead CRC and ensure all action items are resolved prior to the next monitoring visit.
Independently coordinate ongoing and upcoming monitoring assignments.
Conducting study visits over the phone for COVID-19 studies
Knowledge of ICH guidelines, GCP, and the clinical trial study process.
Ability to work effectively in teams as well as independently.
Ability to manage multiple projects at a time.
Our must-haves:
Must attend in-person meetings depending on the status of the pandemic
Must have a fast, reliable DSL, Fiber, or Broadband connection (not mobile or broadband stick) as the primary internet connection with a minimum actual speed of 10MBPS
Must have a backup internet connection of the same speed, if the primary connection becomes spotty
Note: An online assessment of the workspace will also be part of the recruitment process
Status: This is a full-time, permanent position with benefits.
Hardware Provision: Company-issued Laptop will be provided on the first day.
Requirements
What we're looking for:
Proficiency in Microsoft Office Suite
Solid written and verbal communication skills
Ability to track startup of newly awarded studies.
Ability to complete all required paperwork for study startup including regulatory paperwork
Work with the recruitment team and contract team to create compensation language for each upcoming study.
Ability to build e-source study templates (training will be provided)
Design study process flows and staff workstations
Conduct and maintain production meetings for new studies.
Other miscellaneous tasks assigned by the Company
Create a pre-screening questionnaire and ensure it is entered within CRIO in a timely manner
Ensure you have reviewed and are knowledgeable on all active and upcoming protocols
Consenting subjects
Registering subjects within the IWRS system.
Uploading any test results that have been analyzed by study vendors
Reviewing and auditing peers study visits.
Benefits
Perks & Benefits:
Government-mandated contributions: SSS, Philhealth, PagIBIG
13th month pay: computation is based on the salary package of the employee
Attendance Incentive: bi-monthly incentive for employees with perfect attendance
Perks and/or Allowances: Deminimis (non-taxable), benefits of relatively small value intended for the general welfare of employees (meal allowance, rice allowance, clothing, laundry or medical cash)
Paid Leaves: 6 VL to take time off, 6 SL (recuperation), 3 EL (emergency situations), statutory leaves (maternity, solo parent, maternity, etc)
Leave Conversion: maximum of 10 unused leave credits may be converted into cash
Special Leave Privileges: birthday occasions, client-initiated leaves
Healthcare Benefit with one (1) dependent
Life Insurance
Funeral Assistance: Php 5,000
Service Award Incentive: rewards and recognition for employees who will successfully reach 1, 3, 5, 7, or 10 years with the company
One CoreDev IT

Makati City, Metro Manila
Permanent
Full-time