Clinical Research Associate II (CRA II)

Clinical Research Associate II (CRA II)

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.

The Clinical Research Associate II (CRA II) supports the successful execution of clinical investigations by partnering closely with research sites investigators and internal clinical teams. This role is responsible for monitoring and supporting studies throughout all phases including study start-up enrollment maintenance and closeout activities.

The CRA II conducts on-site remote and centralized monitoring activities to ensure compliance with FDA regulations ICH/GCP guidelines study protocols and company procedures. This position also serves as a key resource to research sites by providing training guidance and ongoing operational addition the CRA II may mentor junior clinical research staff and contribute to process improvement initiatives.

Your Responsibilities:

• Conduct on-site remote and centralized monitoring visits in accordance with FDA regulations ICH/GCP guidelines study protocols and company procedures.
• Review study data for completeness accuracy and protocol compliance; identify discrepancies and support resolution of data queries and action items.
• Prepare monitoring visit reports follow-up letters and related study documentation in a timely manner.
• Support study start-up activities including site qualification regulatory document collection IRB submissions and site initiation activities.
• Maintain study files and essential documentation including regulatory records training materials correspondence and investigational product accountability.
• Ensure investigator and site documentation complies with applicable regulations and company standards.
• Provide training and ongoing support to investigators coordinators field clinical staff and internal study teams on protocol requirements and clinical research processes.
• Build and maintain strong working relationships with investigators coordinators and research site personnel.
  
• Identify compliance concerns operational risks and process gaps; collaborate with cross-functional teams to implement corrective actions and solutions.
  
• Assist with the development and review of study-related materials including case report forms monitoring plans training materials and study tools.
  
• Support investigational product/device accountability inventory management and documentation.
  
• Contribute to clinical study operations database development activities investigator meetings and continuous quality improvement initiatives.
  
• Mentor and provide guidance to junior clinical research staff as needed.
  
• Collaborate cross-functionally with internal departments to support clinical study objectives and timelines.
  
• Perform additional duties and support other studies as assigned.

Your Profile

• Bachelors or advanced degree in Life Sciences Nursing or another health-related discipline required.
  
• Minimum of 3 years of CRA experience within the medical device pharmaceutical or CRO industry required.
  
• Strong working knowledge of FDA regulations ICH/GCP guidelines and clinical research processes.
  
• Experience conducting monitoring visits and supporting clinical study execution.
  
• Knowledge or experience in Electrophysiology and/or Neuromodulation preferred.
  
• CCRA or CCRP certification preferred.
  
• Strong organizational time management and problem-solving skills.
  
• Excellent written and verbal communication skills.
  
• Ability to manage multiple priorities in a fast-paced environment.
  
• Strong attention to detail and accuracy.
  
• Proficiency with Microsoft Office applications and clinical database systems.
  
• Ability to work independently and collaboratively within cross-functional teams.
  
• Valid U.S. drivers license required.
  
• Ability to lift and transport up to 25 pounds.

Travel

• Approximately 25% travel is required for site visits monitoring activities investigator meetings training and educational seminars.

Location

• Remote opportunity based within the United States

Are you interested Please apply online through our application management system! We are looking forward to welcoming you.

Location: Remote out of Lake Oswego Oregon Working hours: Full-time Type of contract: Undefined

Apply now under: ID: 62284 BIOTRONIK Inc. United States (US)

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. Please note that applications sent by post will only be returned if a sufficiently stamped self-addressed envelope is included.