Senior Clinical Research Associate | Trials Lead & Mentor

BD; Colorado; On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Health insurance

401(k)

Job summary

Waters seeks a Senior Clinical Research Associate to lead site monitoring across multiple studies, ensuring GCP and regulatory compliance. You will mentor junior CRAs, manage regulatory documentation, and drive risk assessment with proactive issue resolution.

You will leverage CTMS/CDMS systems and collaborate with internal teams and CROs to ensure high-quality study execution in fast-paced environments.

Qualifications

• Experience in clinical trial operations
• Strong knowledge of GCP, regulatory requirements (FDA/ISO), IRB/EC
• Ability to mentor junior CRAs and manage multiple studies

Responsibilities

• Manage site monitoring and relationships across multiple studies (on-site, virtual, remote)
• Ensure compliance with protocol, GCP, FDA CFR, ISO and SOPs
• Review and report AEs/SAEs, manage regulatory documents and TMFs
• Provide mentoring and training for CRAs
• Utilize clinical systems (Veeva Vault CTMS/CDMS) and collaborate with internal teams and CROs

Skills

Clinical trial operations

Regulatory knowledge

Study monitoring

Cross-functional collaboration

Education

Bachelor's degree in healthcare or science

3 years CRA field experience

Tools

Veeva Vault CTMS

Veeva Vault CDMS

Job description

Waters seeks a Senior Clinical Research Associate to lead site monitoring across multiple studies, ensuring GCP and regulatory compliance. You will mentor junior CRAs, manage regulatory documentation, and drive risk assessment with proactive issue resolution.

You will leverage CTMS/CDMS systems and collaborate with internal teams and CROs to ensure high-quality study execution in fast-paced environments.