CRA / 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.
This position requires the candidate to be based on the East Coast of the United States
MAJOR DUTIES AND RESPONSIBILITIES:
- Monitor study progress to ensure compliance with protocol requirements, local regulations (Competent Authorities/FDA) 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 Trial Master File (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 uploaded in TMF and maintained during the lifecycle of the clinical trial(s).
- Support activities for Clinical Event Committee and Data Safety Monitoring Board reviews.
- Complete projects and tasks in a manner consistent with corporate objectives
EXPERIENCE / KNOWLEDGE / SKILL REQUIREMENTS
- 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.