Ctry Approval Assoc
Share
Job Location:
Buenos Aires - Argentina
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Prepares reviews and coordinates under guidance and local EC submissions inalignment with global submission strategy.
Supports preparation under guidance of local MoH submissions as applicable inalignment with global submission strategy.
Coordinates under guidance with internal functional departments to ensure
various site start-up activities are aligned with submissions activities and
mutually agreed upon timelines; ensures alignment of submission process for
sites and study are aligned to the critical path for site activation.
Achieves PPDs target cycle times for site.
May have contact with investigators for submission related activities.
May act as a key-contact at country level for either Ethical or Regulatory
submission-related activities.
Works with the start-up CRA(s) to prepare the regulatory compliance review
packages as applicable.
Assists in developing country specific Patient Information Sheet/Informed
Consent form documents.
Assists with grant budgets(s) and payment schedules negotiations with sites.
Enters and maintains trial status information relating to SIA activities onto PPD
or client (where contracted) tracking databases in an accurate and timely
manner
Ensures the local country study files and filing processes are prepared set up
and maintained as per PPD WPDs or applicable client SOPs.
Maintains knowledge of and understand PPD SOPs Client SOPs/directives and
current regulatory guidelines as applicable to services provided
Qualifications:
Education and Experience:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 0to 2 years).
Working Conditions and Environment:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear garments and gloves.
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
