Clinical Trial Associate

Integrated Resources, Inc ( IRI ); Cambridge (MA); On-site; USD 94,000 - 132,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Delivery Lead to coordinate clinical monitoring activities and oversee CRO management. This role involves ensuring compliance with regulatory requirements and supporting clinical development objectives. Ideal candidates will have a CRA background with experience in therapeutic areas like Neuroscience or Oncology, along with strong organizational and communication skills.

Qualifications

• 1-2 years of lead CRA experience.
• 3 years of field CRA monitoring.
• Strong knowledge of GCP, ICH, and clinical documentation.

Responsibilities

• Coordinate clinical monitoring activities and oversee CRO site management.
• Co-monitor international Ph2/3 clinical studies.
• Manage CRO relationships and participate in RFP processes.

Skills

Organizational abilities

Communication

Teamwork

Proactive attitude

Flexible attitude

Education

CRA graduate

Tools

MS Office

Job description

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Delivery Lead - Recruitment at Integrated Resources, Inc ( IRI )

Pay range - $45/hr-$55/hr

Summary / purpose of the position

The Delivery Lead will coordinate clinical monitoring activities, oversee CRO site management, and co-monitor international Ph2/3 clinical studies, ensuring compliance with regulatory requirements, GCP guidelines, and SOPs. The role aims to support clinical development objectives and achieve clinical excellence.

Main responsibilities include:

1. Ensuring efficient study start-up by overseeing CRO clinical teams and collaborating with relevant departments.
2. Supporting and verifying completion of EDC system tasks and training CRAs.
3. Assisting in timeline evaluation, document preparation, and monitoring plan validation.
4. Managing CRO relationships and participating in RFP processes.
5. Co-monitoring clinical studies, reviewing data, and ensuring timely data collection and study documentation.
6. Participating in audits, inspections, and maintaining key clinical documents.
7. Acting as site CRA or backup to CPM as needed.
8. Contributing to SOP updates, training, and cross-departmental projects.
9. Ensuring compliance with EHS regulations and company SOPs.

Knowledge, abilities & experience

Minimum: CRA graduate with at least 1-2 years of lead CRA experience and 3 years of field CRA monitoring. Strong knowledge of GCP, ICH, and clinical documentation. Experience managing CRO relationships and working in therapeutic areas like Neuroscience or Oncology is preferred.

Skills include proficiency in MS Office, organizational abilities, communication, teamwork, and a proactive, flexible attitude.

Senior level: Mid-Senior

Employment type: Contract

Industry: Pharmaceutical Manufacturing and Biotechnology Research