Senior CRA, Early Development — Remote

Parexel; Santa Fe (NM); Híbrido; USD 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work option

Descripción de la vacante

Parexel is seeking a SrCRA to support monitoring and site management for client-sponsored studies, ensuring adherence to ICH GCP, local regulations, and client SOPs. Activities occur on-site and remotely with CTMS documentation.

Collaboration with CTLs and other functions supports site activation, oversight of data, and timely study deliverables. Strong communication and problem-solving are essential to success.

Formación

• Minimum 5 years of related experience for Sr CRA.
• Strong analytical problem-solving skills and critical thinking abilities.
• Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA).

Responsabilidades

• Perform site management activities to ensure protocol and regulatory compliance.
• Conduct site qualification, initiation, interim, and close-out visits (on-site and remote).
• Collaborate with CTL and other client functions to support site activation and deliverables.
• Establish and maintain professional relationships with investigator site staff and ensure effective communication.
• Perform drug accountability, reconciliation, and destruction in line with protocol requirements.
• Prepare and maintain Oversight Monitoring Plan and review study metrics.
• Write and submit monitoring visit reports and study correspondence.
• Ensure site regulatory files are current and timely in reporting safety data.

Conocimientos

Analytical problem-solving

Communication

Time management

Critical thinking

Educación

Bachelor's degree or equivalent

Herramientas

EDC

CTMS

Microsoft Office

Descripción del empleo

Parexel is seeking a SrCRA to support monitoring and site management for client-sponsored studies, ensuring adherence to ICH GCP, local regulations, and client SOPs. Activities occur on-site and remotely with CTMS documentation.

Collaboration with CTLs and other functions supports site activation, oversight of data, and timely study deliverables. Strong communication and problem-solving are essential to success.