study startup & Regulatory specialistAsia Premier One Source, Inc.

Description An individual who, under the direction and ongoing supervision of the Principal Investigator, aids in the daily function of clinical research programs being performed by the Company and Principal Investigator and any other such Physician Description An individual who, under the direction and ongoing supervision of the Principal Investigator, aids in the daily function of clinical research programs being performed by the Company and Principal Investigator and any other such Physician assigned as an Investigator on protocols being performed by the Company. ESSENTIAL DUTIES AND RESPONSIBILITIES (May include, but are not limited to): 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 the recruitment 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, and 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 comprehend the protocols and have all required system access Schedule and coordinate staff travel for Investigator Meetings Schedule and coordinate pre-site selection visits and site initiation visits Create pre-screening questionnaire and ensure it is centered 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. 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 Requirements Should have at least 1 year work-related experience as a Regulatory Affairs Specialist, Clinical Research Coordinator/Associate Graduate of Bachelor's Degree in Pharmacy, Biology, or any other related medical degree Should have a comprehensive knowledge on FDA, GCP, HIPAA, and other confidentiality agreements and policies on clinical research studiesWilling to work on a shifting schedule Amenable to work onsite at Mandaluyong City Willing to work on a graveyard shift schedule Prior project management experience Skilled in computer and data collection software Certificates, Licenses, Registration (May include but not limited to): Accredited medical degree and/or certification program and/or two years research experience
Monster

Philippines
Permanent
Full-time