Job Description

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.  

• Salary: $125-$140k

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. 

Clinical Resource Network Distinction   

CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve. 

About CRN  

Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn. 

Opportunity Awaits. 

Job Tags

Hourly pay, Permanent employment, Full time, Contract work, Local area, Flexible hours,

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