Clinical Research Associate I - Boston, United States - BRIOHEALTH SOLUTIONS INC

BRIOHEALTH SOLUTIONS INC
BRIOHEALTH SOLUTIONS INC
Verified Company
Boston, United States

1 month ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description
Duties and responsibilities include the following.

  • Set up and maintenance of study files, including administration of the eTMF where used in clinical studies and supporting any use of CTMS
  • Drafting and review of participant information sheets and informed consents
  • Review of CRFs
  • Setting up the clinical study sites, including:
  • Ensuring each center has the clinical trial materials
  • Participating in training of site staff on the clinical study, GCP, applicable regulations
  • General study management including:
- eTMF filing

  • Preparation of annual trial progress reports for IRBs/ECs and Regulatory Authorities
  • Assist in reporting Serious Adverse Event to IRBs/ECs and Regulatory Authorities under
  • Preparing submissions to Institutional Review Boards (IRBs) / Ethics Committees (ECs) and
  • Keeping study trackers/study progress overviews up to date
  • Working together with clinical affairs in database development, and performing User Acceptance Testing(UAT) of the Electronic Data Capture database.
  • Working together with Data Management to obtain a clean database and to solve queries in preparation for
  • Assisting in preparing study related training materials
  • Participating in project meetings and investigator meetings and writing minutes
  • Preparations for audits and inspections
  • Completion of TMF and ISF routine audits
  • Assisting in organizing investigator meetings
Qualification Requirements

Experience

  • B.S. or higher degree in a science related field, or equivalent industry experience
  • Ability to create, implement and evaluate operational and administrative processes
  • Knowledge of US FDA CFR and guidelines applicable to conducting clinical trials (i.e. GCP certification or similar)
  • Proficient in the use of computer and software systems
  • Ability to understand basic and complex medical details
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