Clinical Research Associate - Medical Device - Boston/PHL or DLS
Description of the Job Duties: 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.
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.
REQUIRED experience/skills/education necessary to do the job:- 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
- Interventional Cardiology
- Cardiac Rhythm Management
- Cardiac Electrophysiology
- Neuromodulation
- Urology
- Endoscopy
- 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.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
