Founded in 1963, BIOTRONIK, Inc. is a pioneer in developing innovative technologies and medical devices that save and enhance the quality of life for millions of individuals living with cardiovascular disorders. Our growing success is based on the company’s core values – Accountability, Commitment, Entrepreneurial, Integrity, Quality – thus enabling us to inspire confidence and trust in doctors and patients all over the world. With a dedicated base of employees worldwide, we're continually looking for talented professionals with the passion and drive for excellence to join our mission.
This Regional position can be based in the northeast regions, PA, NJ,or OH,
The Regional CRA is responsible for coordinating and performing all aspects of clinical monitoring in compliance with FDA regulations, ICH/GCP guidelines and company SOPs. The Regional CRA will conduct site visits to determine protocol and regulatory compliance. Ensure integrity of study data is accurate and complete to allow proper evaluation of device performance. Other necessary skills include ability to diffuse and resolve issues at investigative site level and sustain strong communication link with project teams.
- Comprehensively monitors each investigational site according to timelines and procedures mandated by company SOPs.
- Works cooperatively with site coordinators and clinical investigators to schedule required monitoring visits.
- Interfaces with BIOTRONIK Clinical Studies project teams to retrieve copies of in-house files and other monitoring tools to perform monitoring visits.
- Conducts thorough monitoring visits focusing on specific areas such as Administrative Binders, Informed Consent Forms, Case Report Forms (CRF)/Patient Binders and Investigational Inventory Reconciliation.
- Works closely with sites to reconcile data queries within a short period of time and prior to data base locks.
- Reviews edit check listings, generate and reconcile queries to ensure accuracy of data collected
- Completes site’s Monitoring Log at conclusion of visit
- Serves as a resource to investigators, site coordinators, sales representatives, clinical engineers, and other staff members regarding investigational protocols and procedures.
- Provides additional site training and education as necessary.
- Completes Monitoring Visit Reports (MVRs), summarize monitoring visit findings according to timelines and procedures mandated by company SOPs.
- Ensures an interactive discussion with both the principal investigator and site coordinator summarizing findings and action items.
- Reviews monitoring findings with Clinical Studies project teams and provides site documents to update in-house files. Additionally, reviews any serious deficiencies discovered during the monitoring visit with Clinical Studies Management.
- Assists in compliance activities as requested including in-house audits, investigator meetings, and training courses related to monitoring.
- Interfaces with Clinical, Regulatory, Sales and administrative staff as necessary to accomplish the above responsibilities.
Approximately 80% travel required throughout the United States to investigational centers and BIOTRONIK, Inc. corporate office
- Bachelor’s or Graduate level degree in health profession, science and/or engineering field.
- Working knowledge of Electrophysiology, Pacing or Interventional Cardiology
- At least 2+ years field monitoring experience working for a CRO, medical device or pharmaceutical company.
- Excellent clinical trial monitoring skills and current Clinical Research Associate certification preferred.
- Strong working knowledge and understanding of FDA, ICH, GCP regulations governing clinical trials, standard regulatory and clinical practices and current regulatory issues related to clinical research.
- Demonstrated aptitude and knowledge in relevant therapeutic area and ability to learn and integrate new/different therapeutic areas.
- Effective self and time management and organizational skills.
- Excellent written and oral communication skills.
- Strong customer focus and excellent interpersonal skills.
- Ability to work independently and as a part of a team.
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