Remote CRA / Senior Clinical Research Associate

Parexel; Trenton (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

Parexel is seeking a CRA/Sr CRA in the US to ensure delivery of studies at allocated sites, act as main site contact, and monitor study conduct in line with ICH-GCP and local regulations. You will prepare, initiate, monitor, and close sites, update CTMS, manage ISF and drug supplies, and collaborate with LSAD and local study teams to drive timely study progress.

Essential skills include excellent attention to detail, strong communication, collaboration, and English proficiency; willingness to

Qualifications

• Excellent knowledge of ICH-GCP, GMP/GDP.
• Good knowledge of local regulations applicable to clinical trials.
• Good medical knowledge and ability to learn Therapeutic Areas.
• Basic understanding of the drug development process.
• Good understanding of Clinical Study Management including monitoring, drug handling and data management.

Responsibilities

• Monitor sites and ensure study deliverables per plan.
• Coordinate start-up and regulatory maintenance (EC/IRB, regulatory authorities).
• Train, support and advise investigators and site staff.
• Ensure training and inspection readiness; manage ISF and study drug supplies.
• Update CTMS and data management systems; manage site queries and reports.
• Collaborate with Local Study Team and LSAD to drive study progress.

Skills

Attention to detail

Communication skills

Collaboration

Negotiation skills

English proficiency

Local language fluency

Education

Bachelor’s degree in life sciences

Job description

Parexel is seeking a CRA/Sr CRA in the US to ensure delivery of studies at allocated sites, act as main site contact, and monitor study conduct in line with ICH-GCP and local regulations. You will prepare, initiate, monitor, and close sites, update CTMS, manage ISF and drug supplies, and collaborate with LSAD and local study teams to drive timely study progress.

Essential skills include excellent attention to detail, strong communication, collaboration, and English proficiency; willingness to