Clinical Research Associate II (CRA II)

Biotronik•Oswego, IL

4h•Remote

About The Position

BIOTRONIK is a leading manufacturer 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 support. In addition, the CRA II may mentor junior clinical research staff and contribute to process improvement initiatives.

Requirements

Bachelor’s 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.
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. driver’s license required.
Ability to lift and transport up to 25 pounds.

Nice To Haves

Knowledge or experience in Electrophysiology and/or Neuromodulation preferred.
CCRA or CCRP certification preferred.

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.