Senior Clinical Research Associate
New
C
ClinChoiceClinical research
Remote, United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- Fluent in English and local language(s).
- Experience
- At least eight (8) years of clinical research experience, including proven experience as a Clinical Research Associate (CRA) performing on-site monitoring activities.
- Required Skills
- GCPMicrosoft Office
Requirements
- Hold a university degree in a scientific, medical, or paramedical discipline; a nursing or relevant degree or background is preferred.
- Have previous experience working for a CRO.
- Have at least eight years of clinical research experience.
- Have proven experience as a Clinical Research Associate performing on-site monitoring activities.
- Have experience with oncology, respiratory, and complex clinical trials.
- Have strong knowledge of clinical trial operations.
- Have strong knowledge of GCP, ICH guidelines, and other applicable regulatory requirements.
- Be fluent in English and local language(s).
- Have proficiency in Microsoft Office, including Word, Excel, and Outlook.
- Be willing and able to travel to investigative sites as needed.
Responsibilities
- Manage 2–3 clinical trials and assigned site management activities.
- Assist with site selection, evaluation, initiation, and collection of pre-study documentation.
- Train site staff in study procedures and develop training materials with the Training & Qualification Management Unit.
- Conduct periodic on-site and remote monitoring visits and complete monitoring visit reports.
- Review Case Report Forms for accuracy, legibility, completeness, and quality.
- Conduct source data verification and in-house clinical data review, and resolve data queries in a timely manner.
- Manage investigational products and trial materials, including the Investigator Study File and CRFs.
- Coordinate site reporting and follow-up for adverse events and other safety issues.
- Conduct study termination and closeout activities, including archiving, and act as the site's main contact.
- Support study preparation, CRF development, site budget negotiations, submission activities, and CRA I coaching.
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