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.
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 and connect with us on Facebook and LinkedIn .
Opportunity Awaits.
Job Tags
Hourly pay, Full time, Contract work, Local area, Flexible hours,