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.

What ICON can offer you:

• Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

• In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

• At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

• If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

• Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

• Are you a current ICON Employee? Please click here to apply