Senior Clinical Research Associate
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 Senior Clinical Research Associate (CRA) to our Clinical Studies team. The Senior 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 Senior CRA participates in all phases of ongoing clinical investigation(s) including Study Initiation, Enrollment, Data Analysis, and Study
Closure. The Senior CRA contributes to ongoing studies by designing case report forms, monitoring plans, and study and training documents; participates in data management and prepares clinical reports; performs remote, centralized and on-site monitoring; maintains in-house study files; provides
day-to-day study management and site support; and interfaces with site coordinators, investigators, field clinical staff, and other company representatives. The Senior CRA ensures study and site compliance with applicable federal regulations and BIOTRONIK policies and procedures. Provides
mentorship to Clinical Project Associate, CRA I and CRA II staff members in performing day to day responsibilities. The Senior CRA independently leads study or department projects.
YOUR RESPONSIBILITIES:
- Assist with protocol design development. Manage the design process for data collection methods and training materials to meet study endpoints.
- Manage development and review process for essential 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.
- Manage oversight of in-house study files, including original study documents, training documents, inventory, site regulatory documentation, and correspondence during the course of the study. Audit in-house study files for compliance to departmental standards.
- Assist sites with IRB submission process. Assist sites with IRB renewal process and track continuing IRB renewals. Ensure site compliance with IRB requirements.
- Support BIOTRONIK in maintaining current and developing new professional relationships with investigators and sites.
- 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 implementation of corrective and preventive action plans.
- Provide training of site and field personnel in protocol requirements. Develop and oversee training for general research and site management.
- Provide training of site coordinators, investigators, and field clinical staff in collecting data in a timely manner. Ensure appropriate data collection per protocol requirements. Serve as a resource across studies for appropriate data collection methods.
- 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 writing the clinical portion of FDA submissions and/or generating clinical reports and publications.
- Assist in the development and implementation of a study-specific clinical database.
- Assist with study related operations and communication with the scientific committees and Clinical Events Committee as necessary
- Provide input for new project planning, including new studies, and departmental policies and procedures.
- Anticipate study conduct issues and develop contingency plans prior to study initiation. Identify, analyze, and report serious compliance issues, and develop action plan for approval by clinical management.
- Identify and develop solutions for logistical and operational issues and communicate to clinical management, field and site personnel. Provide guidance to departmental staff regarding developing resolutions for logistical and operational challenges.
- Oversee training of newly-hired CPA, CRA I and CRA II staff. Provide leadership for CPA, CRA I and CRA II staff in performing day to day responsibilities for clinical studies.
- 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, review and/or approve Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters per BIOTRONIK procedures and work with site to resolve action items between monitoring visits.
- Assist the CRA Manager with team, department and study related projects as requested including audits, investigator meetings, training, continuous quality improvement, etc.
- Interface with other departments as necessary.
- Provide support and assistance to team members in completing other trials when necessary.
- Provide input on departmental decisions related to process and procedures
- Adhere to and demonstrate proficiency in implementing departmental SOPs and policies. Escalate procedural discrepancies to CRA Manager.
YOUR PROFILE:
- Bachelor's or Graduate degree in a life sciences, nursing or other health related disciplines.
- Minimum 6 years as a CRA in the medical device or pharmaceutical industry or with a CRO.
- 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.
- 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 ability to independently lead study or department projects
- 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, OR or remote within U.S. based on skill set and qualifications
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: 58296 | 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.
