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.
- 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.
- 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.