Note: The job is a remote job and is open to candidates in USA. Piper Companies is seeking a Clinical Research Associate to support a leading organization in the pharmaceutical and biotechnology industry. The role involves independently monitoring clinical research sites, ensuring regulatory and protocol compliance, resolving site issues, maintaining investigator relationships, and completing monitoring documentation while traveling extensively.
Responsibilities
- Conduct site qualification, initiation, routine monitoring, and closeout visits
- Ensure studies are conducted in compliance with ICH-GCP guidelines, protocols, and regulatory requirements
- Review source documentation, site records, and data for accuracy and compliance
- Build and maintain strong relationships with investigators and site staff
- Identify, document, and resolve site issues while supporting overall study execution
- Complete monitoring reports and follow-up documentation within required timelines
- Travel extensively to clinical research sites as required
Skills
- 2+ years of independent monitoring experience as a Clinical Research Associate
- Strong knowledge of ICH-GCP guidelines and clinical trial regulations
- Excellent communication, organization, and problem-solving skills
- Bachelor's degree in a scientific, healthcare, or related field preferred
- Experience within pharmaceutical, biotechnology, or medical device studies preferred
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Long-term career growth
Company Overview
Company H1B Sponsorship