Field Vascular Intervention Specialist Job in Tampa 33601, Florida US
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.
RESPONSIBILITIES:
- Establish, train and maintain clinical sites during all phases of vascular intervention clinical trials.
- Train investigational centers and other BIOTRONIK personnel on study devices and clinical protocols.
- Attend investigational device implants and follow-ups, as a technical and clinical resource for the staff at the investigational center.
- Serve as a resource to site coordinators, investigators and other BIOTRONIK field personnel regarding study devices and clinical protocols.
- Train site and field personnel on data collection methods to ensure collection of patient data that is accurate, complete and conforms to project data standards and protocol requirements.
- Assist site coordinators and investigators in collecting data in a timely manner that meets the protocol requirements.
- Assist the Clinical Research Associate group with on-site monitoring in accordance with BIOTRONIK standard operating procedures to ensure accurate data collection and adherence to FDA and protocol requirements.
- Support BIOTRONIK in maintaining current and developing new professional relationships with investigators and investigative sites.
- Develop solutions for logistical and operational issues that arise during study execution and communicate these in a timely fashion to management, field and site personnel.
- Identify and report serious protocol compliance issues.
- Extensive travel is required (70% of time).
- Minimum of three years experience in a catheterization lab supporting diagnostic testing and implants of vascular intervention products including both peripheral and coronary stents.
- Preference given to candidates with prior experience in the medical device industry, including interaction with physicians during the implantation or intervention with peripheral or coronary stents and/or balloons.
- Degree in health profession, science or engineering field with a strong technical and clinical background. Bachelor or Masters Degree preferred.
- Superior communication skills and the ability to interact professionally with all levels of corporate personnel and customer base.
- Preference given to candidates with working knowledge and understanding of FDA, ICH and GCP regulations governing clinical trials, standard regulatory and clinical practices and current regulatory issues related to clinical research.
- Demonstrated aptitude in, and knowledge of, relevant therapeutic areas and the ability to learn and integrate new/different therapeutic areas.
- Ability to work both independently and as a part of a team.
January 15, 2009
• Tags: Field Vascular Intervention Specialist Job in Tampa 33601, Florida Us • Posted in: General