Study Start Up and Regulatory Specialist

Asia Premier One Source Inc.

  • Mandaluyong, Philippines
    Mandaluyong, Metro Manila, Philippines
    Metro Manila
  • Full time
Posted a month ago and deadline of application is on 30 Jul
Recruiter was hiring a day ago

Study Start Up and Regulatory Specialist

Asia Premier One Source Inc.

Job Description

Role and Responsibilities

The candidate in the role will be responsible for the following key tasks:

  • Ability to track startup of newly awarded studies
  • Ability to complete all required paperwork for study startup including regulatory paperwork
  • Ability to submit IRB paperwork
  • Work with recruitment team and contract team to create compensation language for each upcoming study
  • Ability to build e-source study templates (training will be provided)
  • Maintain and update CVs, training certificates
  • Interact with vendors to ensure all needed study startup forms are completed and submitted to CRO/Sponsor contacts
  • Design study process flows and staff workstations
  • Conduct and maintain production meetings for new studies
  • Interact with marketing and ensure all marketing materials for studies are built and implemented
  • Ensure study staff have completed all required trainings, fully comprehended protocols, and have all required system access
  • Schedule and coordinate staff travel for Investigator Meetings
  • Schedule and coordinate Pre-Site Selection Visits, Site Initiation Visits
  • Other miscellaneous tasks assigned by the Company
  • Create 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
  • QC daily visits and create queries within the CRIO system
  • Send weekly unresolved query report to site manager
  • Ability to track and maintain monitor visits
  • Review all sponsor follow up letters with the study’s Lead CRC and ensure all action items are resolved prior to the next monitoring visit.

Minimum Qualifications

  • Prior project management experience
  • Strong written and verbal skills
  • Proficient with Microsoft Office
  • Must be a graduate of any medical field, preferably, a Registered Nurse, Medical Technology, or Pharmacy
  • Willing to work on night shift, and holidays
  • Willing to work at Mandaluyong City

Perks and Benefits

  • Paid Vacation Leave Paid Vacation Leave
  • Maternity & Paternity Leave Maternity & Paternity Leave
  • Single Parent Leave Single Parent Leave
  • Life Insurance Life Insurance
  • Medical, Prescription, Dental, or Vision Plans Medical, Prescription, Dental, or Vision Plans
  • Company Car Company Car
  • Recruitment / Signing Bonus Recruitment / Signing Bonus

Required Skills

  • Clerical Skills
  • Attention to Detail
  • Customer Service
  • Critical Thinking
  • Data Management
  • Data Encoding / Data Entry
  • Computer Literacy / Basic Computer Skills

Jobs Summary

Job level
Associate / Supervisor
Job category
Administration and Coordination
Educational requirement
Bachelor's degree graduate
Office Address
Mandaluyong, Metro Manila, Philippines
Business Process Outsourcing
1 opening

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About Asia Premier One Source Inc.

Founded in 2007, Asia Premier One Source Inc. (APOSI) emerged in the BPO Industry. Known for having highly-trained specialists, exceptional customer services, and innovative yet cost-efficient solutions. We provide Inbound, Outbound, Non-voice and Process Solutions. Our client’s success is our focus. With this in mind, the company is centered on the core values of Teamwork, Integrity, Quality, Professionalism, Respect, Innovation, Results Orientation, Entrepreneurial Spirit and Excellent Client Relationship.
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