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Our mid-sized medical device client is adding a Sr/Clinical Research Associate to the team. The Sr. CRA is responsible for the initiation and oversight of clinical centers to ensure the successful conduct of active clinical studies. The Sr. Clinical Research Associate will ensure that clinical centers perform the clinical study according to the study protocol and regulatory standards by qualifying, training, monitoring and overseeing study conduct at multiple clinical centers.
Your role with the company:
- Identify and assess the suitability of clinical study centers for participation in clinical trials
- Train clinical centers on the clinical study protocol, data collection and good clinical practices
- Site Management; Communicate directly with clinical centers to maximize enrollment, ensure quality and timely data capture and answer study-related questions
- Assist in mentoring Junior monitors
- Perform remote and on-site monitoring visits at participating clinical study centers to ensure the safety of study patients, the reporting of accurate study data and appropriate study management at the clinical study center
- Document site visits by preparing visit reports and follow-up letters to the clinical study centers
- Assist clinical centers with the preparation of IRB/EC submissions
- Collect and archive study related documentation and correspondence
- Communicate monitoring and site management updates to the internal clinical team
- Assist with the development of the clinical study Monitoring Plan
- Develop training materials and other study-related documentation
- Maintain clinical monitoring tracking tools for each clinical study
- Assist with other clinical related duties as assigned
- Document product and therapy field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed
- Complete training requirements and competency confirmations as required for this position within the required timeline
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement
Desired Profile:
- Bachelor’s Degree (BA or BS) preferred; Science Degree preferred
- Previous experience in clinical research (minimum 3 -5 years required) specifically monitoring and site management
- Previous training and understanding of GCP and 21 CFR 812 required
- Ability to travel up to approximately 30% required (about 2x/month)
- Experience with clinical study documentation, clinical data and data capture institutional review boards
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