Our client is looking to fill the role of Sr. CRA located in the suburbs of Boston, MA. This will require a local candidate who has the interest and flexibility to meet the high demands of travel and have a desire to be in an office a few times a month to collaborate with cross functional team members.
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%
Opportunity Awaits.
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