Field-Based Clinical Research Associate/Monitor

Planet Pharma; Maryland; Hybrid; USD 75,000 - 110,000; Full time

Job summary

Planet Pharma is seeking a Clinical Research Associate to conduct site monitoring for clinical trials in accordance with SOPs, ICH guidelines, and GCP. You will manage site activities, perform initiation and close-out visits, and ensure protocol and regulatory compliance.

Travel up to 75% is required, with a college degree or allied health certification and 5+ years of clinical research experience preferred. Experience with eCRF platforms and strong attention to detail are essential.

Qualifications

• Requires college degree or allied health certification.
• Minimum 5 years of clinical research experience in healthcare, pharma, or CRO settings; 2 years of field monitoring as a CRA.
• Phase I experience preferred.
• Valid Driver’s License.

Responsibilities

• Manage and monitor site activities for assigned clinical studies, solo or with other CRAs.
• Conduct site qualification, initiation, interim monitoring, and close-out visits.
• Ensure protocol, SOPs, FDA regulations, and ICH-GCP compliance during monitoring visits.
• Perform site evaluations of potential investigators and assess site capabilities.
• Initiate studies with site personnel, review protocol and regulatory issues, and train on CRFs and monitoring tasks.
• Resolve issues to support site file audits and ensure timeline adherence.
• Coordinate communications with investigational sites for visits, queries, action items, and data submission.
• Document storage conditions and accountability of clinical trial materials; manage product inventory and disposition.

Skills

Clinical Research

Site Monitoring

ICH-GCP

FDA Regulations

Travel 75%

eCRF

Education

College degree or allied health certification

Tools

eCRF platforms

Job description

Planet Pharma is seeking a Clinical Research Associate to conduct site monitoring for clinical trials in accordance with SOPs, ICH guidelines, and GCP. You will manage site activities, perform initiation and close-out visits, and ensure protocol and regulatory compliance.

Travel up to 75% is required, with a college degree or allied health certification and 5+ years of clinical research experience preferred. Experience with eCRF platforms and strong attention to detail are essential.