Job Description

Our client is looking to fill the role of Sr. CRA.

Responsibilities:

• Supports the Clinical Operations Lead in managing site performance and addressing site issues to align with project goals and timelines.
• Conducts comprehensive co-monitoring visits (PSVs, SIVs, IMVs, COVs) with CRO to ensure compliance with the clinical trial protocol, SOPs, ICH-GCP, and other regulatory requirements.
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region if delegated.
• Coordinates resolution of site audit findings.
• Provides regular updates to internal stakeholders on trial progress, CRO performance relating to site monitoring and site management activities, and any issues or risks that may impact study deliverables.
• Supports the Clinical Operations Leads in maintaining and/or monitoring project timelines and participant enrollment and implementing respective corrective and preventive measures.
• Supports the development and review of study materials, including CRFs and informed consent documents.
• Assists with developing training materials and support; leads site training sessions and ensures accurate documentation and data collection in clinical trials.
• Assists with the management and resolution of data queries to maintain data integrity.
• Contributes to the ongoing quality review and final reconciliation of the Trial Master File (TMF).
• Proactively identifies potential risks and issues that may arise with studies, CROs, and vendors, and make recommendations to address in an effective manner.
• Performs clinical supplies and lab sample management with vendors on a country and regional level.
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
• Supports Clinical Operational Lead in budget planning, tracking and reconciliations.  
• Contributes to the development of department processes and best practices.
• Adheres to GCP/ICH guidelines and Acumen SOPs.
• Other duties as assigned

Required Qualifications:

• Excellent organizational, communication, interpersonal, and problem-solving skills. Ability to manage external vendors while working collaboratively in a fast-paced environment
• Must be flexible and able to work in a dynamic, fast paced environment
• Ability to work independently and as part of a team
• Microsoft Office 365 (Word, Excel, PowerPoint, Teams, Outlook, Microsoft Project)
• DocuSign and Adobe
• EDC/RTSM
• eTMF
• Clinical Research certification (e.g., ACRP, SOCRA) is a plus
• University/college degree in science
• At least 4 years of clinical research experience, including at least 2 years as a Clinical Research Associate (CRA) within the pharmaceutical/biotech or CRO industry
• Previous experience overseeing or co-monitoring with CROs is highly desirable
• Strong knowledge of clinical trial methodology, GCP, ICH guidelines, and regulatory requirements
• Ability to travel up to 30%

If you meet the required qualifications and are interested in this role, please apply today. 

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Job Tags

Permanent employment, Flexible hours,

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