Senior Clinical Research Associate
Description: The responsibility of a Senior Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.
- Ability to achieve objectives with minimal to no supervision. Alternatively, take on the role of a CRA Coordinator on smaller projects
- Shows solid understanding of therapeutic indications and study hypothesis.
- Represent function in external client meetings and presentations such as investigator meetings and site visits
- Perform co-monitoring visits as required to achieve objectives
- Build relationships with investigators and site staff
- Perform on site visits in accordance with the monitoring plan
- Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
- Monitor and maintain ICH-GCP compliance
- Responsible for the completeness and quality of the on-site files
- Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
- Excellent interpersonal, verbal and written communication skills
- Able to take initiative and work independently *Sense of urgency in completing assigned tasks
- Able to travel as needed to achieve study objectives
Requirements
- Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience
- Competent in written and oral English
- Substantial monitoring experience or equal experience in clinical research
Submit Your Resume
To submit your resume for our file or Curriculum Vitae‚ please send an email with your resume or CV to hr@anthera.com. Please send your resume or CV in Word or PDF format and reference the job title of the position.
Thank you for your interest.
Principals Only. No Recruiters.
