Senior Clinical Research Associate - Remote Trials Lead

Parexel; Augusta (ME); On-site; USD 85,000 - 120,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate I to oversee site management, monitoring and close-out of investigator sites across trials, ensuring patient safety and adherence to GCP and client standards.

The role requires leading site delivery from activation to database lock, active collaboration with the Site Care Partner and study team, and substantial travel (60–80%). English fluency and oncology experience are highly valued.

Qualifications

• Bachelor's degree in life sciences or related field required.
• 3+ years of clinical research site monitoring experience ( Oncology preferred).
• Strong knowledge of ICH-GCP, FDA regulations and local country requirements.
• Fluent in English; local language skills as applicable.
• Willingness to travel 60–80% within region and some international travel.

Responsibilities

• Oversee monitoring responsibilities and study conduct to meet SMP, timelines and quality.
• Manage operational aspects from site activation to database lock.
• Serve as primary contact for investigator sites and coordinate with SCP for site delivery.
• Facilitate information flow among study team, vendors and investigator sites.
• Provide site development and training to ensure protocol compliance and patient safety.
• Attend investigator meetings and support site activation and recruitment.
• Conduct onsite and remote monitoring and manage site close-out activities.
• Monitor AEs/SAEs and assist with timely reporting and follow-up.

Skills

Clinical trial monitoring

GCP/ICH-GCP

FDA/regulatory knowledge

English fluency

Travel readiness

Stakeholder communication

Site relationship management

Oncology/Vaccines/IM/ID experience

Education

Bachelor's degree in life sciences

Job description

Parexel is seeking a Senior Clinical Research Associate I to oversee site management, monitoring and close-out of investigator sites across trials, ensuring patient safety and adherence to GCP and client standards.

The role requires leading site delivery from activation to database lock, active collaboration with the Site Care Partner and study team, and substantial travel (60–80%). English fluency and oncology experience are highly valued.