Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun! As an Orthofix employee, you will become an integral part of our culture by continually demonstrating the highest level of integrity and our beliefs while making an impact to our vision “To be a highly respected global orthopedic and spine company that delivers exceptional value to our patients, customers, team members, partners and shareholders."
Clinical Research Associate III
How you’ll make a difference?
To initiate, monitor pre-clinical and clinical research studies for the purpose of obtaining approvals for new indications or products, as well as to support ongoing evaluations of existing Orthofix products. To assist CRA I in these same activities.
What will be your Duties and Responsibilities?
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- Ensure compliance with all FDA regulations and ICH – GCP guidelines for conducting clinical studies.
- Assist with the preparation of study contracts and agreements.
- Assist with the design and/or review of synopses and protocols for new clinical research trials and ongoing evaluations of marketed products.
- Solicit protocol input and feedback from appropriate advisors.
- Screen and recruit clinical investigators.
- Assist in the IRB application process, including review of informed consent / HIPAA forms for conformance to FDA regulations.
- Train and monitor investigators and their staff for study participation.
- Ensure sites receive and maintain adequate study supplies.
- Prepare and maintain study regulatory binders.
- Assure data integrity through proper monitoring, verification of source records, documentation of protocol deviations, and completion of written reports, in accordance with department Standard Operating Procedures (SOPs).
- Maintain project tracking systems and provide accurate progress reports on assigned studies and sites.
- Identify study site issues, implement corrective action, and document results.
- Ensure subject safety in all areas of clinical research, following procedures to report SAEs and UADEs to clinical and regulatory management.
- Promote good communication within the Clinical team, as well as between other Orthofix departmental team members.
- Contribute to the compilation of FDA submissions.
- Regular attendance required.
What skills you’ll need?
- Bachelor’s Degree or equivalent experience.
- Industry experience in clinical research, including two+ years as a CRA performing field-based monitoring.
- Demonstrated knowledge of FDA regulations and ICH – GCP guidelines.
- Ability to handle new challenges and solve unexpected problems.
- Excellent communication skills required.
- Must work both independently and in a team environment.
- Proficient computer skills using Microsoft Office products.
- Proficiency with Medidata Rave preferred.
NONESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS (not necessary but preferred):
- Certification through a professional organization such as ACRP, SOCRA, or RAPS.
- Medical terminology in Orthopedics.
- Experience with device trials involving IDE – PMA submissions and post-market surveillance.
PHYSICAL DEMANDS AND WORK CONDITIONS:
The physical demands described here 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.
- Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as computer, printer, copier, fax, and telephone. Occasionally required to reach overhead, bend, and lift objects (up to 20 lbs.).
- Eyesight and hearing must be correctable to standard level.
- If renting a car a valid driver's license is required.
- Minimum of 50% Travel required.
Orthofix complies with all applicable federal, state, and local laws regarding equal employment opportunities (EEO) to all employees and applicants for employment. Orthofix makes its employment decisions without regard to race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law. In addition to federal law requirements, Orthofix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.