Clinical Research Associate I
BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company
headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.
BIOTRONIK is looking to add a Clinical Research Associate (CRA) to our Clinical Studies team. The Clinical Research Associate (CRA) is responsible for working with research sites and the clinical
research team to facilitate the successful and timely conduct of clinical investigation(s), building relationships, and effectively communicating ideas and results. The CRA participates in most phases of ongoing clinical investigation(s) including Study Initiation, Enrollment, and Study Closure.
The CRA contributes to ongoing studies by performing on-site monitoring visits; remote monitoring visits; centralized monitoring, following up on monitoring visit action items; maintaining site files and Trial Master Files; providing day-to-day study management and site support; interfacing with
site coordinators, investigators, field clinical staff, and other company representatives. The CRA ensures study and site compliance with applicable federal regulations and BIOTRONIK policies and procedures.
YOUR RESPONSIBILITIES:
- Assist in the review of protocols, data collection methods and training materials.
- Assist in the development and review of study documents, including nomination and screening forms, monitoring plan, informed consent and study agreements.
- Ensure that documentation from investigators and study sites meets FDA and BIOTRONIK requirements.
- Prepare and maintain complete and accurate site files and Trial Master Files, including original study documents, training documents, inventory, site regulatory documentation, and correspondence during the
course of the study. Audit sponsor study files for compliance to departmental standards.
- Assist sites with IRB submission process. Assist sites with IRB renewal process and tracks continuing IRB renewals. Ensure site compliance with IRB requirements.
- Support BIOTRONIK in maintaining current and developing new professional relationships with investigators and study sites for assigned study.
- Demonstrate critical thinking to recognize data discrepancies, compliance, and/or regulatory issues and interface with site staff and project team for resolution.
- Identify and report serious compliance issues to clinical management and participate in implementing action plans.
- Provide training to site and field personnel in protocol requirements.
- Provide training to site coordinators, investigators, and field clinical staff in collecting data in a timely manner that meets the protocol requirements. Assist site coordinators, investigators, field clinical
staff, and sales representatives in collecting data appropriately.
- Review data submitted to BIOTRONIK for completeness and accuracy.
- Review aggregate clinical data for scientific validity and interface with project team to resolve discrepancies.
- Assist in the development and implementation of a study-specific clinical database.
- Identify logistical and operational issues and work with clinical management to develop solutions. Effectively communicates solutions to field and site personnel.
- Conduct on-site and remote monitoring visits as well as centralized monitoring within timelines and according to the monitoring plan and BIOTRONIK procedures. Apply FDA regulations, ICH/GCP guidelines and
BIOTRONIK procedures to monitoring activities.
- Create professional, accurate and succinct queries and action items per BIOTRONIK procedures and follow queries and action items to resolution.
- Complete and review Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters per BIOTRONIK procedures and work with sites to resolve action items between monitoring visits.
- Provide input on departmental decisions related to process and procedures
- Interface with other departments as necessary
- Provide support and assistance to team members in completing other trials when necessary
- Adhere to and demonstrate proficiency in implementing departmental SOPs and policies. Escalate procedural discrepancies to CRA Manager.
- Assist the CRA Manager with team, department and study related projects as requested including audits, investigator meetings, training, continuous quality improvement, etc.
YOUR PROFILE:
- Bachelor’s or Graduate degree in a life sciences, nursing or other health related disciplines.
- Must have a valid US driver’s license.
- 2 years clinical research experience in medical device or pharmaceutical industry or CRO as a CRA, clinical trial assistant, or similar role.
- Strong working knowledge, understanding and ability to apply FDA regulations and ICH/GCP guidelines governing clinical trials.
- Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP) is preferred.
- Demonstrated aptitude and knowledge in relevant therapeutic area (Electrophysiology, Vascular Interventional Cardiology and Neuromodulation) and ability to learn and integrate new or different therapeutic
areas.
- Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands.
- High attention to detail and accuracy
- Proficient knowledge of medical terminology
- Excellent time management and organizational skills.
- Excellent professional writing and oral communication skills.
- Excellent interpersonal skills.
- Ability to work independently as well as part of a team.
- Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)
- Ability to lift 25 or more pounds.
WORK LOCATION:
Lake Oswego, Oregon preferred, or remote within U.S. based on skill set and qualifications
TRAVEL REQUIREMENTS:
Approximately 25% travel may be required be required for site training, investigator meetings, monitoring responsibilities, and educational seminars.
POSITION TYPE AND EXPECTED HOURS OF WORK:
- This is a full-time position. Standard days of work are Monday through Friday. Evening and weekend work may be required as job duties demand.
PHYSICAL REQUIREMENTS:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to be independently mobile.
- The employee is also required to interact with a computer for extended periods of time, and communicate with co-workers.
Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.
Location: Lake Oswego, OR | Working hours: Full-time | Type of contract: Undefined
Apply now under: www.biotronik.com/careers
Job ID: 58295 | BIOTRONIK Inc. | USA
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression,
national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.
