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