study site CoordinatorAsia Premier One Source, Inc.

Study Coordination
Conduct study visits over the phone for COVID-19 studies
Consenting subjects
Registering subjects within the IWRS system
Entering data within our EMR system and the sponsors EDC portal
Uploading any test results that have been analyzed by study vendors
Reviewing and auditing peers study visits
Study Startup
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 visits
Candidates should have at least 2 years related work experience in Clinical Research or as a Study Coordinator
College Graduate of Bachelor's Degree in Pharmacy, Biology, or other related medical degree
Comprehensive knowledge of FDA, GCP, HIPAA, Confidentiality agreements, and policies
Familiar with EMR tools (Medidate and Rave)
Good Clinical Practice Certification is a huge plus!
Experienced with project management
Willing to work on a shifting schedule, night shift, weekends, and holidays
Willing to work onsite
Single Parent Leave
Medical / Health Insurance
Paid Sick Leave
Recruitment / Signing Bonus
Life Insurance
Paid Vacation Leave
Maternity & Paternity Leave
Other:
Weekly Attendance Bonus
Entry Level / Junior, Apprentice Health and Medical Business Process Outsourcing 1 opening Bachelor's degree graduate
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.
Kalibrr

Mandaluyong City, Metro Manila
Permanent
Full-time