Senior CRA: Remote/On-site with 80% Travel

Emmes; Rockville (MD); Hybrid; USD 90.000 - 140.000; Vollzeit

Zusammenfassung

Emmes is seeking a Senior Clinical Research Associate to monitor study sites both remotely and on-site, ensuring compliance with ICH GCP and regulatory requirements. The role involves coordinating site visits, reviewing informed consent, verifying data, and supporting site staff with training under supervision.

The ideal candidate will have 4–6 years of monitoring experience, strong MS Office skills, and meticulous attention to detail.

Qualifikationen

• :Bachelor's degree or equivalent work experience required.
• 4–6 years monitoring experience (on-site and remote).
• Proficient with MS Office Suite.
• Excellent computer and organizational skills.
• Exceptional attention to detail.
• Ability to work on varying projects with minimal oversight.
• Remote work ability and cross-functional collaboration.

Aufgaben

• Schedule and conduct remote and on-site monitoring visits (qualification/pre-study, site initiation, interim, closeout, for cause).
• Conduct ICF reviews, source data verification, ADE reporting, protocol deviations, site file reviews, IP/ID/storage checks, and site tours.
• Document observations in site visit reports with minimal reviewer feedback.
• Facilitate Action Item resolution post-visit.
• Ensure compliance with protocol/SOPs/ICH GCP and regulatory requirements.
• Provide training and retraining to site staff under supervision.

Kenntnisse

Monitoring experience

Attention to detail

Critical thinking

Self-starter (remote)

Team player

Clinical research operations

Oral and written communication

Prioritization

Problem solving

Collaboration

Ausbildung

Bachelor's Degree in Scientific discipline

Tools

MS Office Suite

Jobbeschreibung

Emmes is seeking a Senior Clinical Research Associate to monitor study sites both remotely and on-site, ensuring compliance with ICH GCP and regulatory requirements. The role involves coordinating site visits, reviewing informed consent, verifying data, and supporting site staff with training under supervision.

The ideal candidate will have 4–6 years of monitoring experience, strong MS Office skills, and meticulous attention to detail.