Senior Clinical Research Associate
Piper Companies is currently seeking a Senior Clinical Research Associate (CRA) for a remote/work from home opportunity with a large global clinical research organization. The Senior Clinical Research Associate will perform and coordinate all aspects of clinical monitoring and site management in accordance with ICH, GCP, FDA guidelines, and local and organizational regulations.
Responsibilities of the Senior Clinical Research Associate:
- Oversee research sites to ensure accuracy of patient records to clinical notes for validation.
- Assess investigational product through physical inventory and records review and report document observations in a timely manner using approved business writing standards.
- Escalate issues to CTM, propose solutions, and track deficiencies to resolution. Maintain contact with investigative sites to confirm protocol is being followed.
- Conduct Monitoring tasks in accordance with the approved monitoring plan.
- Provide progress reports and status tracking to the CTM.
- Participate in investigator meetings as needed to identify and ensure the acceptability of qualified investigative sites.
- Respond to company, client, and federal requirements/audits.
Qualifications of the Senior Clinical Research Associate:
- 2+ years of experience as a clinical research monitor or previous experience that provides the appropriate knowledge, skills, and abilities.
- Bachelor’s degree in a life sciences related field or a RN Certification
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
- Effective clinical monitoring skills
- Excellent understanding of GCPs and applicable SOPs
- Ability to travel 60-70%
Compensation for the Senior Clinical Research Associate:
- Salary Range: $90,000 - $140,000 based on previous salary history and experience