Senior CRA, Early Development (Remote)

Parexel; Annapolis (MD); Híbrido; USD 90.000 - 140.000; Jornada completa

Descripción de la vacante

Parexel is seeking a Sr Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. Activities span on-site and remote interactions with investigator sites, CTLs, and CRO partners, ensuring adherence to ICH GCP and regulatory requirements.

The role involves oversight of monitoring activities, data integrity checks, and collaboration with cross-functional teams to meet study deliverables.

Formación

• Bachelor's degree or equivalent.
• Minimum of 5 years of related experience for Sr CRA.
• Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (FDA, EMA, PMDA).
• Proficiency with IT applications including Microsoft Office, EDC, CTMS, and data repositories.
• Strong analytical, problem-solving and critical thinking abilities.

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 strong relationships with investigator site staff and ensure effective communication.
• Review site source documentation and verify accurate data capture (ALCOA principles).
• Prepare and maintain Oversight Monitoring Plan and monitor CRO CRA performance.

Conocimientos

Strong communication

Analytical problem-solving

Interpersonal skills

Regulatory awareness

Time management

Educación

Bachelor's degree or equivalent

Herramientas

Microsoft Office

EDC

CTMS

Data repositories

Descripción del empleo

Parexel is seeking a Sr Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. Activities span on-site and remote interactions with investigator sites, CTLs, and CRO partners, ensuring adherence to ICH GCP and regulatory requirements.

The role involves oversight of monitoring activities, data integrity checks, and collaboration with cross-functional teams to meet study deliverables.