Medacta® is an international orthopaedics company specializing in the design and production of innovative orthopaedic products and the development of accompanying surgical techniques. Established in 1999 in Switzerland, Medacta’s products and surgical techniques are characterized by innovation. Medacta is a pioneer in developing new offerings on the basis of the minimally invasive surgical techniques, in particular its Anterior Minimally Invasive Surgery (AMIS®) technique for hip replacements. Medacta has leveraged its orthopaedic expertise and comprehensive understanding of the human body to develop the sophisticated MySolutions technology, which offers surgeons highly personalized pre-operative planning and implant placement methodologies by creating advanced personalized kinematic models and 3D planning tools for use in hip, knee, shoulder and spine procedures.

Medacta is looking for a Clinical Research Associate to assist in designing, planning and conducting high quality clinical research trials sponsored by Medacta USA.  Medacta USA Headquarters is located in Cool Springs/Franklin, TN. 

Medacta values medical education, innovation and healthcare sustainability! 

Position Title:  Clinical Research Associate                                                 FSLA Status:  Salary – Exempt       

Department:    Clinical Research, Medacta USA                                               Location: Franklin, TN

Supervisor:  Associate Director, Clinical Research         

Position Summary

The Clinical Research Associate will assist in designing, planning and conducting high quality clinical research trials sponsored by Medacta USA. The  Clinical Research Associate will act as central point of communication between the Sponsor and Investigators for clinical trial related activities to assure trials are conducted on time, while fully GCP, ICH and SOP compliant.  The CRS II will be responsible for the coordination of clinical research studies sponsored by Medacta. Serve as the liaison between the IRB, the Principal investigators and Sponsor.

Job Specifications

Knowledge:

Minimum Educational Requirements: Bachelor’s Degree in a related healthcare discipline mandatory. Certified clinical research professional preferred. Knowledge of IRB policies, ICH GCP guidelines, FDA regulations.

Minimum Experience Requirements: 4+ years of clinical research experience, orthopedic surgery preferred.

Minimum Skill Requirements: Experience with on-site monitoring of clinical research trials.  Strong interpersonal and proactive communication skills. Ability to communicate effectively both verbally and in writing. Ability to maintain tact, poise, and discretion in handling confidential matters. Highly organized and detail oriented. Ability to convey complex information in understandable terms to individuals at all educational levels. Ability to analyze and solve problems. Ability to handle multiple tasks concurrently. Excellent time management skills.

Equipment or Machines Used: PC, Microsoft Office software suite,  office equipment.

Principal Duties:  

·         Implement clinical trial plans and execute clinical trial protocols study objectives;

·         Ensure consistent study execution through the development of supporting study documents such as Clinical Investigation Plans, Case Report Forms, Data Management Plans, and Monitoring Plans;

·         Assume role to facilitate communication between sites and company to increase value proposition to investigators.

·         Develop monitoring plan and participate in monitoring visits (as delegated by the supervisor) according to monitoring plan.

·         Manage study supplies for sites and company.

·         Develop a timeline for every phase of each project at each site, monitoring the progress, anticipate/estimate potential delays and proactively implement whatever is necessary to keep the process moving.

·         Conduct clinical site management daily activities and monitor program metrics to ensure consistent and predictable study progress;

·         Ensure delivery of high quality data according to agreed timelines, ensuring adherence to international and local regulations and SOP standards

·         Actively identify issues and challenges that present barriers to program success and develop and implement appropriate solutions;

·         Conduct site initiation and study closeout activities as delegated by the supervisor and provide training to site personnel

·         Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures;

·         Track and report on progress of study including, start-up phase such as IRB submissions, approvals, budgets and contracts, site activation, patient enrollment, monitoring visits;

·         Investigate issues, monitor discrepancies, and follow up until resolution;

·         Perform clinical data review, source data review, source data verification, and including query generation;

·         Assist in negotiating budgets, preparing contracts, and IRB/EC approval with sites and investigators.

·         Ensure that work is performed in accordance with scope of work in order to validate site invoices;

·         Assist with vendor training on protocols and procedures-

·         Report to and interact with Assoc Director, Clinical Research, Medacta USA on a regular basis to ensure adherence to study goals and timelines

·         Must be able to travel up to 30%.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this position. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel sofied.