Perform site management and act as the primary liaison to the investigator and site staff
Conduct Site Evaluation, Site Initiation, Interim Monitoring, Close-out, and other study-specific visits
Assist with the preparation of appropriate training materials
Evaluate the quality and integrity of site practices to ensure GCP compliance
Manage site and study progress by tracking regulatory submissions and data query resolution
Ensure the collection and maintenance of required essential documents
Train site staff on proper preparation and handling of investigational products
Develop a patient recruitment plan in conjunction with the site
Verify informed consent and proper reporting of adverse events
Ensure deviations from regulations are documented and communicated appropriately
Assist with the coordination of investigator and study meetings

Requirements

Experience monitoring clinical trials with rater-administered measures preferred
Certified Clinical Research Associate (CCRA) credentialing is preferred
Knowledge of the clinical research discipline, GCP, and ICH-E6 is essential
Proficiency with systems (CTMS, EDC, eTMF) and MS Office (Word, Excel, Outlook)
BS in scientific discipline or pharmacy, RN, or BSN degree, or equivalent combination of education and experience
Minimum 2 years of experience in relevant CRO/biotech/pharmaceutical industry, including on-site or remote monitoring experience

Benefits

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial monitoringGCP compliancedata query resolutionpatient recruitment planninginformed consent verificationadverse event reportingregulatory submissions trackingsite evaluationsite initiationinterim monitoring

Soft Skills

communicationtrainingorganizational skillsliaison abilitiesproblem-solving

Certifications

Certified Clinical Research Associate (CCRA)