Onsite Clinical Research Associate — Site Lead & Monitoring

Parexel; Augusta (ME); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

Parexel is seeking a Clinical Research Associate (CRA) in Maine with at least one year of onsite monitoring experience. You will manage clinical sites from initiation to closeout, serving as the primary contact and ensuring study quality, patient safety, and regulatory compliance.

You will conduct onsite visits, support enrollment timelines, and collaborate with investigators across therapeutic areas. The role offers growth paths within clinical research and requires strong communication and

Qualifikationen

• Direct onsite monitoring experience (12+ months) as a CRA.
• Bachelor’s degree or equivalent in biological science, pharmacy, or another health-related discipline.
• Knowledge of Good Clinical Practice and regulatory requirements.
• Experience with CTMS, EDMS, and MS Office (Excel/Word).
• Strong interpersonal, written, verbal, organizational, and problem-solving skills.
• Oncology, Ophthalmology, CAR-T, or MASH trial monitoring experience preferred.

Aufgaben

• Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites.
• Manage site quality and delivery from site identification through closeout.
• Serve as the primary contact for assigned clinical sites and resolve issues to support study execution.
• Oversee study integrity and build relationships with investigators and site staff.
• Review trial performance and safeguard participant rights, safety, and well-being.
• Develop patient recruitment strategies with clinical sites to support enrollment timelines.
• Ensure compliance with SOPs, study protocols, GCP, and regulatory requirements.
• Evaluate data quality and site performance, and verify regulatory documentation.
• Monitor completeness and quality of regulatory documentation and perform site document verification.

Kenntnisse

Interpersonal skills

Written and verbal communication

Organizational skills

Problem-solving

Independent work

Client-focused

Team collaboration

Attention to quality

Ausbildung

Bachelor’s degree or equivalent in biological science, pharmacy, or another health-related discipline

Tools

Clinical Trial Management System

Electronic Document Management System

Microsoft Office (Excel, Word)

Jobbeschreibung

Parexel is seeking a Clinical Research Associate (CRA) in Maine with at least one year of onsite monitoring experience. You will manage clinical sites from initiation to closeout, serving as the primary contact and ensuring study quality, patient safety, and regulatory compliance.

You will conduct onsite visits, support enrollment timelines, and collaborate with investigators across therapeutic areas. The role offers growth paths within clinical research and requires strong communication and