study startup & Regulatory specialistAsia Premier One Source, Inc.

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):
Answer inbound calls and recruit patients to studies
Recruit study patients by cold calling subjects from database
Develop, procure and post study recruitment marketing documents
Pre-screen study participants before and after study activation
Review and understand clinical research protocols to ensure study inclusion and exclusion criteria are fully understood
Conduct all required study startup recruitment tasks on assigned study protocols
Communicates effectively and courteously with study patients
Demonstrates a caring attitude toward patients and their families
Acknowledges study patients' needs and tends to them appropriately
Collects patient medical history and conditions
Collect and evaluate concomitant medication
Collect and evaluate medical records for compliance
Other tasks and responsibilities as requested by the Company to facilitate business needs
Requirements
Comprehensive knowledge of FDA, GCP and HIPAA as applied to clinical research
Knowledge of current studies being conducted
Comprehensive knowledge of company's SOPs, policies and Confidentiality agreements
Skilled in computer and data collection software
Spanish bilingual speaker
Certificates, Licenses, Registration (May include but not limited to):
Accredited medical degree and/or certification program and/or two years research experience
CPR and first aid certification
GCP and protection of Human Subject Participants
Workable

Mandaluyong City, Metro Manila
Permanent
Full-time