Senior CRA, Phase I Expert — Site Oversight

Parexel; Santa Fe (NM); On-site; USD 90,000 - 120,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. The role ensures adherence to ICH GCP, local regulations, and client SOPs. You will interact with investigator sites and cross-functional teams to meet study deliverables.

Responsibilities include site visits, oversight monitoring, data review, and documentation. Strong communication, problem solving, and regulatory knowledge are essential for success in this

Qualifications

• Bachelor's degree (or equivalent) required.
• Minimum of 5 years of related experience for Senior CRA.
• Working knowledge of ICH GCP, FDA/EMA and local regulations.
• Strong analytical, problem solving and written reporting skills.

Responsibilities

• Perform site management and monitoring to ensure protocol and regulatory compliance.
• Conduct qualification, initiation, interim, and close-out visits on-site or remotely.
• Collaborate with CTL and other client functions to support site activation and deliverables.
• Maintain site relationships and ensure effective communication with investigator staff.
• Review data capture, perform drug accountability, and ensure ALCOA principles.

Skills

Analytical problem solving

Effective communication

Time management

Prioritization

Written reports

Education

Bachelor's degree

Tools

EDC

CTMS

MS Office

Data repositories

Job description

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. The role ensures adherence to ICH GCP, local regulations, and client SOPs. You will interact with investigator sites and cross-functional teams to meet study deliverables.

Responsibilities include site visits, oversight monitoring, data review, and documentation. Strong communication, problem solving, and regulatory knowledge are essential for success in this