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At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

The Clinical Research Associate (CRA) will participate in the preparation and execution of a variety of clinical research initiatives, including approval trials, post-market activities, registries surveys and other initiatives. The CRA will oversee the progress of clinical research related activities, either independently or in coordination with internal stakeholders and external vendors as required by conducting site evaluation, initiation, interim monitoring, and close out visits to sites to ensure ongoing compliance with applicable regulations, ICH/GCP guidelines, and protocol requirements. The CRA will also facilitate the identification, qualification, and initiation of clinical sites.

Key Responsibilities:

1. Assist Clinical Affairs leadership and team members in developing study-specific investigator/site requirements to enable identification and qualification of potential clinical sites
2. Develop study-specific training for site initiation visits as aligned with Clinical Affairs leadership
3. Assist in the preparation and support of research site qualification and site initiation visits
4. Perform on-site and remote monitoring and study closure activities across multiple protocols
5. Ensure that sites operate in compliance with study protocols, SOPs, ICH/GCP guidelines, and applicable regulations
6. Monitor, track, and support patient enrollment and study progress
7. Ensure the timely, accurate, and complete collection and submission of study data
8. Liaise with investigators and staff prior to study initiation to ensure all aspects of study are understood, confirm appropriateness of IRB and ensure that all documentation required to initiate study is complete
9. Maintain and track regular correspondence with sites through email or telephone
10. Proactively identify, address, and resolve issues and problems at the clinical site as they might occur
11. Manage required study documentation through accurate filing in the designed Trial Master File system
12. Prepare monitoring reports
13. Assist in distribution and tracking of regulatory documents
14. Assist Clinical affairs leadership and team members in development of study and site budgets
15. If applicable, facilitate activities to enable payment for sites
16. Hold oneself and others accountable to conduct business in a manner compliant with Bioventus’ Code of Compliance, policies and procedures and internal controls applicable to their role.

Education and Experience (Knowledge, Skills & Abilities)

• Minimum 4 year degree in Health-related field (e.g., nursing, physical therapy, public health); Registered Nursing certification or equivalent licensure from an appropriately accredited institution will also be considered. ACRP or similar certification highly desirable.
• Demonstrated understanding of medical terminology
• Demonstrated ability to attain and maintain a working knowledge of current ICH/GCP guidelines and application in accordance with Standard Operating Procedures (SOPs) as applicable; may contribute to the development and/or review of relevant SOP’s
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel, including surgeons and surgical staff
• Excellent attention to detail with demonstrated organizational and time management skills
• 2-5 years industry experience
• Computer literate and proficient in MS Office; knowledge of electronic capture preferred

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Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.