Job Description

Senior Clinical Research Associate (Sr. CRA)

Location: Morristown, NJ/Hybrid

Salary: Base salary up to $100k plus 15% bonus and Cash Long Term incentive plan.

Our biopharmaceutical client located in Northern NJ area has tasked Scientific Search with finding a Senior Clinical Research Associate. This role will support the planning, execution, and tracking of clinical trials across all phases of development.

Responsibilities

• Assist with study start-up activities, including site selection, regulatory submissions, and essential document collection.
• Maintain Trial Master File (TMF) in compliance with ICH-GCP and company standards; support TMF quality control and audit readiness.
• Track and manage site and vendor communications, contracts, payments, and milestones.
• Collaborate with CROs and study sites to ensure timely resolution of issues and support site monitoring efforts.
• Conducts site management (e.g. device accountability, Investigator credentialing, and research staff training) including Sponsor Oversight Visits. Review and/or generate Co-monitoring/Sponsor Oversight Visit reports.
• Participate in the preparation and follow-up/resolution of regulatory authority inspections as well as internal audits, site audits and other quality audits.
• Assists and/or manage activities and interactions with contractors, CROs, and/or vendors
• May perform on-site monitoring, audit and verify data entered on eCRFs are complete accurate and consistent with source data. Generate MVRs after each visit.
• Maintains all relevant documentation and communications as part of study files including review of TMF for completeness
• Assist with clinical data reconciliation efforts and review of clinical data listings as needed.

Requirements

• Bachelor’s degree or equivalent required in science/health preferred
• 3-5 years clinical operations/study management experience including site monitoring (knowledge of audit preparation and sponsor oversight monitoring a plus)
• Solid understanding of ICH-GCP, FDA, and EMA regulatory requirements.
• Experience with electronic Trial Master File (eTMF) systems and CTMS platforms preferred.

How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to [email protected] and tell me why you’re interested. Or, feel free to email your resume.

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