Sr. Clinical Research Associate

Job Description – Sr. CRA

To coordinate all clinical research activities required to ensure data integrity such as data monitoring, protocol compliance, and study documentation, in accordance with Good Clinical Practices.

Responsibilities

  • Monitor study progress to ensure compliance with protocol requirements, FDA regulations and Good Clinical Practices.
  • Assist in all aspects of study start up activities including document preparation of patient informed consent forms and study materials for institutional review board (IRB/EC) submission and approvals.
  • Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with company’s SOPs, GCP and ICH Guidelines.
  • Conduct site qualification, site initiation, interim monitoring and close-out visits in accordance with the monitoring plan and resolve any issues with sites.
  • Assess potential study sites to ensure the facility, staff and patient population are adequate for study conduct.
  • Ensures all regulatory documents and study supplies are maintained during the lifecycle of the clinical trial(s).
  • Support activities for Clinical Event Committee and Data Safety Monitoring Board reviews.
  • Serves as a mentor for junior CRAs and CTAs and those new to the company and/or trial.


Qualifications

  • BA/BS in Life Sciences or another medical-related field.
  • Minimum 5 years related experience in managing global clinical trials for medical devices
  • Must have experience managing study startup, monitoring, and closeout activities.
  • Data management, EDC development, Safety, and vendor management experience is preferred.
  • Proficiency with computer software such as MS Outlook, Word, PowerPoint, Excel, MS Project/Smartsheet is required.
  • Must have knowledge of ISO 14155, FDA regulations (23 CFR Part 11, 50, 54, 56, 812) and ICH Good Clinical Practice.
  • Must be detailed-oriented and can manage multifaceted tasks of a clinical study
  • Excellent interpersonal, organizational, problem-solving,
  • Ability to work effectively with a wide variety of research personnel.
  • Travel is required 25 – 50% as needed.
  • Excellent written and verbal communication skills including medical writing
  • Good time management and ability to prioritize tasks and accomplish set goals efficiently.