Clinical Research Associate II — Global Site Monitoring & QA

Parexel; Hartford (CT); On-site; USD 70,000 - 110,000; Full time

Job summary

Parexel in the United States is seeking a Clinical Research Associate (CRA) responsible for the site management, monitoring and close-out of assigned investigator sites to ensure patient safety and adherence to GCP and sponsor standards. The CRA will be accountable for site management, monitor relationships, enrollment support, data queries, and timely TMF documentation.

You will partner with the Site Care Partner to develop investigator sites, provide coaching and training, and conduct onsite

Qualifications

• Minimum 2 years monitoring experience in clinical research site monitoring.
• Fluent English; ability to work in local language(s).
• Ability to travel 60-80%.
• Bachelor’s degree in life sciences or related field.

Responsibilities

• Ensure proper conduct of clinical trials per SMP, laws, GCP and sponsor standards to meet goals.
• Manage site activation through database lock, ensuring timelines and quality deliverables.
• Serve as primary contact for assigned investigator sites; coordinate with SCP for site delivery quality.
• Interface with study team, vendors, and investigator sites to facilitate information flow.
• Provide investigator site development, coaching and training to ensure protocol compliance and patient safety.
• Attend investigator meetings (virtual or in person) and support enrollment, remediation and recruitment at site level.
• Conduct onsite, remote/electronic monitoring for site initiation, routine monitoring and close-out activities.
• Monitor site-level adverse events and collaborate with Drug Safety for SAEs resolution.
• Submit TMF documentation, site reports, protocol deviations, recruitment metrics and other updates on time.
• Identify and resolve site issues; implement corrective actions to prevent recurrence.
• Close-out activities and data query resolution within required timelines.
• Oversee investigational product handling, storage, and destruction at sites; support database release.
• May perform unblinded monitoring when required.

Skills

Clinical trial methodologies

ICH/GCP

FDA regulations

Travel 60-80%

Fluent English

Driver's license & passport

Education

Bachelor’s degree in life sciences

Job description

Parexel in the United States is seeking a Clinical Research Associate (CRA) responsible for the site management, monitoring and close-out of assigned investigator sites to ensure patient safety and adherence to GCP and sponsor standards. The CRA will be accountable for site management, monitor relationships, enrollment support, data queries, and timely TMF documentation.

You will partner with the Site Care Partner to develop investigator sites, provide coaching and training, and conduct onsite