Part-Time Clinical Research Associate (Home-Based) East Coast
- Expired: over a month ago. Applications are no longer accepted.
The qualified candidate will:
-Reside on the East Coast/ Central US
-Perform clinical data review of data listings and summary tables, including query generation
-Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits
-Develop and maintain good working relationships with investigators and study staff
-Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study specific manuals and procedures
-Track and report on progress of study including site activation, patient enrollment, monitoring visits
-Investigate queries, monitor discrepancies
-Manage investigational product (IP) accountability and reconciliation process
-Negotiate and manage the budget and payments for investigative sites, if applicable
-Knowledge of FDA and International Conference of Harmonization (ICH) Guidelines
-Excellent written and communication skills
-Strong operational, organizational, presentation, documentation and interpersonal skills
-Bachelors Degree in science/health related field
-Nursing Degree is preferred
-Minimum 2-3 years experience as a CRA in the pharmaceutical/biotech industry
National Research Services
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