CRA
ICON Strategic Solutions
Summary
Monitors progress of clinical studies at the site level to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements. Provides both on-site and remote support in start-up, enrollment, follow-up and closure of clinical trial activities.
Job description
Key Responsibilities
- Source Review: conducts thorough review of subject source documents to ensure protocol requirements are met, captured and reported to the sponsor and IRB, as applicable.
- Source Verification: conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records. Issue, investigate and resolve data discrepancies.
- Communications: ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence. Thorough documentation and proper escalation of issues is essential in all visit reports.
- Training: ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitor and maintain site personnel list, qualification and training records.
- Site Compliance: ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. Support regulatory inspection activities as required.
- Event Reporting: ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
- Collaboration: participates in study-specific meetings teleconferences and trainings as required. Collaborates with cross-functional team members and study sites throughout all study phases.
- Documentation: work with In-house CRA team as needed to request / collection of relevant (i.e., Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database.
Requirements
- Minimum of 1 year of medical device experience
- Minimum of 2 years of site monitoring experience
- Bachelor's degree or Registered Nurse (RN) qualification
- Ability to travel up to 60%
- Therapeutic experience aligned with at least one Boston Scientific division
- Proficient with MS Office skills (Word, Excel, PowerPoint, Teams)
- Prior experience with Medidata RAVE and VEEVA Vault preferred
- The candidate should be based in or near Philadelphia, Boston, or Dallas.
Benefits
- Annual Leave
- Health Insurance
- Retirement Planning
- Employee Assistance Programme
- Life Assurance
- Childcare Vouchers
- Bike Purchase Schemes
- Discounted Gym Memberships
- Subsidized Travel Passes
- Health Assessments
Company overview
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services, operating as a specialized division of ICON plc. As the world's largest FSP provider with over 90 partnerships globally and more than 14,000 dedicated employees, the company offers embedded clinical research expertise within pharmaceutical and biotechnology organizations. ICON Strategic Solutions delivers comprehensive FSP models that provide cost-savings, clinical expertise, and significantly improve business performance for sponsors. The company specializes in deploying dedicated teams across all major clinical development functions including clinical monitoring, project management, data management, statistical programming, pharmacovigilance, and regulatory affairs. With headquarters in Dublin, Ireland and operations spanning multiple global locations, ICON Strategic Solutions enables pharmaceutical and biotech companies to access specialized talent and operational excellence while maintaining flexibility in their clinical development programs. The organization focuses on delivering innovative clinical research solutions that accelerate drug development timelines and enhance the quality of clinical trial execution across therapeutic areas including oncology, cardiovascular diseases, central nervous system disorders, and rare diseases.