Clinical Research Associate

This is a fully remote position, open to applicants in Massachusetts, +2 more states.

📋 Description

• Oversee the advancement of clinical studies at the site level to ensure subject rights and welfare, data precision and completeness, and adherence to protocol, SOPs, ISO/GCP, and relevant regulations.

• Offer both on-site and remote assistance throughout the phases of clinical trial initiation, enrollment, follow-up, and conclusion.

• Examine subject source documents to confirm that protocol standards are fulfilled and accurately reported.

• Cross-check Case Report Form data with source documents and validate informed consent forms.

• Assess regulatory documents and device accountability logs; investigate and rectify data inconsistencies.

• Maintain communication with clinical sites and project team members through monitoring reports, follow-up letters, study memos, and other correspondence.

• Educate site personnel and keep records of their qualifications and training.

• Address, document, and escalate any issues of site non-compliance; assist with regulatory inspection processes.

• Identify, document, and report events that require attention.

• Engage in study-specific meetings, teleconferences, and training sessions.

• Collaborate with cross-functional team members and study sites throughout all phases of the study.

• Partner with the In-house CRA team to gather and review investigator/site documentation and authorize relevant database documents.

⛳️ Requirements

• At least 1 year of experience in the medical device sector.

• A minimum of 2 years of experience in site monitoring.

• Bachelor’s degree or qualification as a Registered Nurse (RN).

• Willingness to travel up to 60%.

• Therapeutic experience related to at least one Boston Scientific division: Interventional Cardiology, Cardiac Rhythm Management, Cardiac Electrophysiology, Neuromodulation, Urology, or Endoscopy.

• Proficient in MS Office applications (Word, Excel, PowerPoint, Teams).

• Previous experience with Medidata RAVE and VEEVA Vault is preferred.

• Candidate should reside in or near Philadelphia, Boston, or Dallas.

• Must have the legal right to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.