CLINICAL RESEARCH ASSOCIATE - CRO
Home based position, anywhere in the U.S.
As a Clinical Research Associate you'll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - III, ensuring adherence to applicable regulations and principles of ICH-GCP.
RESPONSIBILITIES
- Work independently and proactively to coordinate all necessary activities required to set up and monitor a study, complete accurate study status reports and maintain study documentation.
- Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested.
- Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required.
- Manage sponsor generated queries efficiently and responsible for study cost effectiveness.
- Assist in training and mentoring less experienced CRA's and/or manage CRA's working on international projects.
REQUIREMENTS
- Minimum of 6 months of active independent field monitoring experience- all types of visits.
- College degree in medicine, science, or equivalent
- Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data
- Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner.
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