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Clinical Research Associate Iii - Remote

Company

Orthofix
Address , Remote
Employment type FULL_TIME
Salary
Expires 2023-06-15
Posted at 1 year ago
Job Description
Why Orthofix?

We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning!
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 SeaSpine and 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!
How you'll make a difference?
To design, initiate and 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 lead and assist junior CRAs in these same activities.

What will be your Duties and Responsibilities?
  • Promote good communication within clinical department, as well as with other Orthofix department members.
  • 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).
  • Regular attendance required.
  • Assist with the analysis of study data.
  • Assist R&D, marketing, and other departments in performing their duties, as appropriate.
  • Oversee day-to-day operations of assigned project and implement measures to ensure success.
  • Assist with the development of written and verbal presentations of study data for symposia, scientific presentations and exhibits, and FDA submissions.
  • Ensure compliance with all FDA regulations and ICH – GCP guidelines for conducting clinical studies.
  • Assist with the handling of clinical study-related questions from doctors, patients, and sales force, as appropriate.
  • Contribute to the compilation of FDA submissions.
  • Screen and recruit clinical research investigators (and laboratories, as applicable).
  • Ensure subject safety in all areas of clinical research, following procedures to report SAEs and UADEs to clinical and regulatory management.
  • Organize and assist with the implementation of investigator meetings (as applicable).
  • Review scientific literature for technological applications and valid animal and clinical models.
  • Assess study site issues, implement corrective action, and document results.
  • Solicit protocol input and feedback from appropriate advisors.
  • Develop project tracking systems and provide accurate progress reports on assigned studies and sites.
  • Assist Sales Training by presenting clinical data from Orthofix studies.
  • Qualify, train, and monitor investigators and their staff for study participation.
  • Design and/or review synopses and protocols for new clinical research trials and ongoing evaluations of marketed products.
  • Ensure high quality, timely and accurate clinical research, with attention to detail.
  • Maintain awareness of current issues in clinical research by reading relevant literature and attending industry meetings and other training opportunities.
  • Lead and mentor CRA I and CRA II in activities and functions as necessary to support assigned projects.
  • Plan budgets, negotiate contracts and prepare agreements for the conduct of clinical trials at investigative centers.
What skills you'll need?
  • Excellent decision-making skills.
  • Demonstrated knowledge of FDA regulations and ICH – GCP guidelines.
  • Bachelors Degree in a medical or scientific discipline.
  • Demonstrated understanding of anatomy, physiology, and medical terminology required.
  • Ability to effectively manage a study from start to finish.
  • Familiarity with principles of research design and basic statistics.
  • Must work both independently and in a team environment.
  • Excellent communication skills required to effectively work with all individuals including the sales force and staff at study sites.
  • Proficient computer skills using Microsoft Office products.
  • Ability to handle new challenges and solve unexpected problems.
  • Significant industry experience in clinical research, three to five+ years as a CRA performing field-based monitoring preferred.
Nonessential Skills, Experience and Qualifications (not necessary but preferred):
  • Certification through a professional organization such as ACRP, SOCRA, or RAPS.
  • Experience with device trials involving IDE – PMA submissions and post-market surveillance.
  • Medical terminology in Orthopedics.
Supervisory Responsibilities:
  • N/A
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.
  • Eyesight and hearing must be correctable to standard level.
  • Travel required.
  • 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.).
We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.
This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.