Clinical Research Associate

BIOTRONIK, Inc.

Location: Portland, Oregon-Portland 97035
Posted on: 10/9/2008 4:05:38 PM
Postion type: Full time
Job Code: 1310
Required Education: High school or equivalent
Salary:

DESCRIPTION
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 conditions. With a growing base of over 3,600 employees worldwide, we're continually looking for talented professionals with the passion and drive for excellence to join our mission.

BIOTRONIK, Inc. now has an exciting opportunity available for a Clinical Research Associate in beautiful Portland Oregon.

POSITION SUMMARY:

The Clinical Research Associate actively works with research sites and the clinical research team to facilitate the successful and timely conduct of clinical investigation(s), build relationships, and effectively communicate ideas and results. Participates in all phases of ongoing clinical investigation(s) including Study Initiation, Enrollment, Data Analysis, and Study Closure. Contributes to ongoing studies by assisting in the design of case report forms, study and training documents; participates in data management and assists in the preparation of clinical reports; performs site monitoring visits; in-house case report form review; maintains in-house study files; provides day-to-day study management and site support; interfaces with site coordinators, investigators, field clinical staff, other company representative. Ensures study and site compliance with applicable federal regulations and BIOTRONIK policies and procedures.

RESPONSIBILITIES:

• Ensure that documentation from investigators and study sites meets FDA and BIOTRONIK requirements.
• Produce and maintain complete and accurate in-house study files, including original study documents, training documents, inventory, site regulatory documentation, subject data files, and correspondence during the course of the study.
• Assist in the design of case report forms and training materials using department templates for sound and through data collection to support the data analysis in accordance with the protocol.
• Study document development and review, including informed consent and study agreements.
• Assist sites with the IRB approval process and track continuing IRB renewals.
• Assist with training of site and field personnel in data collection methods to ensure collection of patient data that is accurate, complete, and conforms to project data standards and protocol requirements.
• Assist in the development and implementation of a study-specific database for clinical studies.
• Actively participate in data management, including organizing data in systematic manner to allow for efficient and accurate clinical reports.
• Review patient study records submitted to BIOTRONIK including case report forms, source-documents, consent forms, and other materials.
• Assist site coordinators, investigators, field clinical staff, and sales representatives in collecting data in a timely manner that meets the protocol requirements.
• Identify logistical and operational issues that arise during study execution in a timely fashion, and work with senior CRA staff and clinical management to develop solutions. Effectively communicate these solutions to field and site personnel.
• Perform on-site and/or in-house monitoring, when applicable, in accordance with BIOTRONIK Standard Operating Procedures, to ensure accurate data collection and adherence to FDA and protocol.
• Identify and report serious compliance issues to senior CRA staff and clinical management, and participate in developing action plans.
• Interface with site staff to resolve data discrepancies, compliance, and/or regulatory issues.
• Serve as a resource to site coordinators, investigators, sales representatives, and other staff members regarding study devices and protocols.
• Assist in writing the clinical portion of FDA submissions and/or generating clinical reports and publications.
• Interface with clinical, regulatory, sales, and administrative staff as necessary to accomplish the above responsibilities.
• Provide input on departmental decisions related to process and procedures.
• Support BIOTRONIK in maintaining current and developing new professional relationships with investigators and investigative sites.
• Provide support and assistance to team members in completing other trials when necessary.
• Perform other clinical duties as requested.

TRAVEL:

• Up to 25% travel would be required be required for site training, investigator meetings, monitoring responsibilities, and educational seminars.

REQUIREMENTS:
• Bachelor’s or graduate degree in health profession, science and/or engineering field.
• 1-2 years experience in the medical device, pharmaceutical industry, or as a site research coordinator.
• Familiarity with medical terminology and abbreviations.
• Knowledge of FDA regulatory requirements.
• Ability to work independently and as a part of a team.
• Excellent written and oral communication skills.
• Excellent computer skills and database management experience.
• Excellent organizational skills and attention to detail. Label