Phase I Senior CRA: Site Oversight & Monitoring

Parexel; Trenton (NJ); Hybride; USD 90 000 - 140 000; Plein temps

Résumé du poste

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for sponsored studies in a US setting. You will coordinate with CTLs and client teams, perform visits on-site and remotely, and ensure study deliverables meet quality standards.

The role requires 5+ years of CRA experience, strong regulatory knowledge, and proficient use of CTMS/EDC tools to maintain accurate, timely documentation and data integrity.

Qualifications

• Bachelor's degree or equivalent required.
• Minimum of 5 years of related experience for Sr CRA.
• Strong analytical and problem-solving skills.
• Working knowledge of clinical drug development and regulatory guidelines.

Responsabilités

• Perform site management and monitoring activities per protocol and ICH GCP.
• Conduct qualification, initiation, interim, and close-out visits, on-site and remote.
• Collaborate with CTL and other client teams to support site activation.
• Maintain relationships with investigator site staff and ensure effective communication.
• Review source documentation and ensure data accuracy (ALCOA).
• Prepare monitoring reports and oversee regulatory binder contents.

Connaissances

Site management

Monitoring visits

ICH GCP

Regulatory knowledge

Communication skills

CTMS familiarity

Data review

Problem solving

Formation

Bachelor's degree

Outils

CTMS

EDC

Description du poste

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for sponsored studies in a US setting. You will coordinate with CTLs and client teams, perform visits on-site and remotely, and ensure study deliverables meet quality standards.

The role requires 5+ years of CRA experience, strong regulatory knowledge, and proficient use of CTMS/EDC tools to maintain accurate, timely documentation and data integrity.