Scientific Search
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
and tell me why you’re interested. Or, feel free to email your resume.
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
and tell me why you’re interested. Or, feel free to email your resume.