Senior CRA

Meet Life Sciences Ltd.; Massachusetts; On-site; USD 110,000 - 140,000; Full time

Job summary

Meet Life Sciences Ltd. is seeking a Senior Clinical Research Associate (CRA) to independently monitor clinical trial sites in compliance with ICH-GCP guidelines.

The role emphasizes site monitoring, source data verification, regulatory documentation, site management, and budget negotiations. The ideal candidate has 5-7 years of independent site monitoring experience, and hands-on work in Neurology or Psychiatry trials, including studies involving Schedule I controlled substances.

Qualifications

• Bachelor's degree in Life Sciences, Clinical Research or related field (or equivalent).
• 5-7 years of independent clinical site monitoring experience.
• Experience in Neurology or Psychiatry clinical trials, including Schedule I controlled substances.

Responsibilities

• Conduct onsite monitoring visits including source data verification and regulatory document assessment.
• Identify and resolve data discrepancies with timely escalation and documentation.
• Ensure protocol compliance, participant safety, and accurate reporting of adverse events.
• Manage site regulatory documentation, investigator files, contracts, and essential study documents.
• Review and approve site documentation including CVs and medical licenses.
• Negotiate site budgets and support site management throughout the trial lifecycle.
• Maintain compliance with ICH-GCP, ISO 14155 and study-specific procedures.

Skills

Site monitoring

Source data verification

Regulatory documentation

Site management

Budget negotiations

ICH-GCP

ISO 14155

Neurology trials

Psychiatry trials

Schedule I substances

Education

Bachelor's degree in Life Sciences/Clinical Research

Job description

We are seeking an experienced Senior Clinical Research Associate (CRA) to independently monitor clinical trial sites, ensuring compliance with study protocols, ICH-GCP guidelines, and applicable regulatory requirements. This role is responsible for site monitoring, source data verification, regulatory documentation, site management, and study budget negotiations. The ideal candidate has experience in Neurology or Psychiatry clinical trials, including Schedule I controlled substances, and thrives in a fast-paced, sponsor-focused environment.

Responsibilities

• Conduct onsite monitoring visits, including source data verification, informed consent review, and regulatory document assessment.
• Identify, investigate, and resolve data discrepancies while ensuring timely issue escalation and documentation.
• Ensure protocol compliance, participant safety, and accurate reporting of adverse events and other reportable events.
• Manage site regulatory documentation, investigator files, contracts, and essential study documents.
• Review, collect, and approve site documentation, including financial disclosures, CVs, and medical licenses.
• Negotiate site budgets and support site management activities throughout the clinical trial lifecycle.
• Maintain compliance with ICH-GCP, regulatory requirements, and study-specific procedures.

Qualifications

• Bachelor's degree in Life Sciences, Clinical Research, Healthcare, or a related field, or equivalent combination of education and experience.
• 5-7 years of independent clinical site monitoring experience and site management within clinical research.
• Required: Experience in Neurology or Psychiatry clinical trials, including clinical studies involving Schedule I controlled substances.
• Strong knowledge of ICH-GCP, ISO 14155, and applicable regulatory requirements.
• Experience with clinical trial site management, regulatory documentation, and budget negotiations.