Clinical Research Assistant

Position Title: Clinical Research Assistant                                                      FSLA Status: Salary - Exempt                                                                                      

Department: Clinical Research                                                                        Location: Franklin, TN/Remote

Supervisor: Director, Clinical Research                                                                                                                                                            

Medacta® is a Swiss-based orthopedic company founded in 1999, renowned for its innovative products and surgical techniques. Notably, they pioneered the Anterior Minimally Invasive Surgery (AMIS®) technique for hip replacements, MyKA Kinematic Alignment Platform for knee replacement, and NextAR Augmented Reality Surgical Platform for use in shoulder, spine, and knee procedures. Leveraging their extensive orthopedic expertise, Medacta introduced MySolutions technology, which provides surgeons with highly personalized pre-operative planning and implant placement methodologies. Utilizing advanced personalized kinematic models and 3D planning tools, MySolutions enhances surgical precision in hip, knee, shoulder, and spine procedures. Medacta's blend of orthopedic expertise and cutting-edge technology drives continual advancements in the field, enhancing patient care worldwide.

Under the direction of the Director of Clinical Research, the Clinical Research Assistant is responsible for assisting in the operations and administrative duties of the Medacta USA (MUSA) routine clinical trial activities. The role is responsible for ensuring that MUSA’s clinical research activities are performed to the highest quality and ethical standards.  The position will require flexibility and the ability to work both independently and in a small team environment.

Educational Requirements:

Bachelor’s Degree preferred. In lieu of degree, experience will be considered.  Medical and clinical field experience preferred.

Experience Requirements:

PC, Microsoft Office software suite, general office equipment. 

Required Skills and Abilities:

• Excellent interpersonal and communication skills.  Demonstrated ability to communicate effectively (verbally and writing). 
• Ability to prioritize and manage the workload, and, as required, be able to manage shifting priorities. based on critical deadlines so that production needs are always met.
• Ability to maintain confidentiality.
• Ability to work independently.
• Organizational Skills – can orchestrate multiple activities at once to accomplish goals, uses resources effectively and efficiently; arranges information and files in a useful manner.
• Physical Requirements:
  • Sitting: Extended periods at a desk or workstation.
  • Standing and Walking: Occasional movement within the office.
  • Lifting and Carrying: Light to moderate lifting of office materials.

Additional tasks may require reaching, manual dexterity, and visual acuity.

External: Clinical study professionals, clinical research related vendors, minimal clinical research site contact.

Internal: Clinical Research team, Marketing, R&D, Finance.

Travel requirements: 0%

Extent of Confidential Information: This position occasionally will encounter confidential information which will be treated according to the company policy to ensure all information is protected.

Reporting: Clinical updates to internal colleagues.

• Perform all other duties as assigned by the clinical research team
• Organizing clinical research materials, such as site TMF binders, providing site materials as needed
• Oversee day to day clinical research assistant operations for the clinical research team
• Assist with filing research study documents in MUSA’s Trial Master File
• Assist in Institutional Review Board (IRB) submissions or related activites as needed
• Providing support for multiple clinical research projects; reviewing and training on clinical research systems as needed, keeping up with clinical team and site training
• Reviewing clinical research payment processing and reconciling vendor/site payments

• Performs other related duties as assigned.

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 so classified.