Clinical Research Associate

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

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

Supervisor: Director, Clinical Research

MEDACTA INTRODUCTION

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.

POSITION SUMMARY

Under the direction of the Associate Director of Clinical Research, the Clinical Research Associate is responsible for monitoring 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. The position is located at the Medacta USA headquarters in Franklin, TN.

QUALIFICATIONS

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.

Experience Requirements:

Minimum 2-3 years' experience in prior related clinical research role

Required Skills and Abilities:

• PC, Microsoft Office Suite, general office equipment
• 2 years of clinical research experience, clinical monitoring experience preferred.
• Experience with on-site monitoring of clinical research trials.
• Ability to work independently, including off-site travel.
• Strong computer skills, including prior experience with clinical research data systems.
• Ability to maintain tact, poise, and discretion in handling confidential matters.
• Highly organized and detail oriented. Ability to analyze and solve problems.
• Ability to manage multiple tasks concurrently.
• Excellent time management skills.
• Physical Requirements

• • Sitting: Extended periods at a desk or workstation.
  • Standing and Walking: Frequent movement within the office.
  • Lifting and Carrying: Light to moderate lifting of office materials, supplies, etc.

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

INTERPERSONAL CONTACTS

External: Medical professionals, surgeons, nurses, clinical study professionals, clinical research related vendors

Internal: Marketing, Research and development, Clinical Research

Travel requirements: 40-50% depending on project needs

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

PRINCIPAL DUTIES

• Manage day-to-day clinical research activities, including efficient activation and start-up of clinical trial sites according to study timelines, maintaining routine contact with sites and contract research organizations (if applicable), drafting case report forms, and writing clinical reports/publications.
• Support the development of clinical trial documentation and systems including clinical protocols, data systems, study reports, for review by head of Clinical Research.
• Perform monitoring and/or auditing of investigative sites, CROs, and MUSA study files.
• Ensure site compliance while conducting qualifications, study initiation, routine monitoring, and study site close-out visits for research sites according to Medacta's Standard Operating Procedures (SOPs);
• Provide training and guidance to Principal Investigator and site staff regarding compliance with research regulations and guidelines, the clinical protocol, and data collection requirements.
• Assist in reporting and follow-up of clinical unexpected and Serious Adverse Event (SAE) reporting.
• Ensure all critical documents related to clinical trials are organized and maintained in audit-ready condition.
• Monitor study investigation of product, supply inventory, and destruction according to SOPs and regulations.
• Ensure quality completion of visit reports, follow-up letters, and maintenance of study-related databases and electronic data capturing portals.

OCCASIONAL DUTIES

Other duties may be assigned at Medacta USA's discretion.

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.