Clinical Research Associate  Employer Information

Organization Name: Medacta USA

Website: www.medacta.com

About Our Organization:

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.

Department: Clinical Research

Reports To: Associate Director, Clinical Research

Job Location: Franklin, TN-37067

Hours/Week: 40

Benefits

 

·   401k

·   Dental Insurance

·   Health Insurance

·   Holidays

·   Sick Leave

·   Vacation

FLSA Status: Exempt

Job Purpose 

Under the direction of the Associate Director of Clinical Research, the Clinical Research Associate is responsible for monitoring 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.

Tasks

 ·   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 development of clinical trial documentation and systems including clinical protocols, data systems, study reports, for review by head of Clinical Research;

·   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 investigational 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;

·   Conduct travel according to company policy, which is expected to be between 50-70% (or may be less due to virtual site monitoring) yet may fluctuate depending on project needs;  

Work Activities 

·   Establishing and Maintaining Interpersonal Relationships

·   Getting Information

·   Organizing, Planning, and Prioritizing Work

·   Communicating with Supervisors, Peers, or Subordinates

·   Documenting/Recording Information

·   Updating and Using Relevant Knowledge

·   Scheduling Work and Activities

·   Interacting With Computers

Physical Demands

the employee is occasionally Climb or balance; the employee is frequently Stoop, kneel, crouch, or crawl; the employee is regularly Stand; Walk; Sit; Use hands to finger, handle, or feel; Reach with hands and arms; Talk or hear;

Lifts Weight or Exerts Force Work Environment

the employee is occasionally Up to 25 pounds; the employee is regularly Up to 10 pounds;

Visions

Specific vision abilities required by this job include Close vision; Distance vision; Ability to adjust focus;

Work Environment

the employee is occasionally Work near moving mechanical parts; Work in high, precarious places; the employee is regularly Fumes or airborne particles; Outdoor weather conditions; Extreme cold (non-weather); Extreme heat (non-weather);

Education and Experience

Years of Experience; 2

Education; Bachelor's Degree

License, Certificate Or Registration; Certified clinical research professional

Additional Information; Knowledge of IRB policies, ICH GCP guidelines, FDA regulations.

Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.

Reading Comprehension

Understanding written sentences and paragraphs in work related documents.

Writing

Communicating effectively in writing as appropriate for the needs of the audience.

·   Speaking

Talking to others to convey information effectively.

·   Critical Thinking

Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.

Social Skills

·   Coordination Adjusting actions in relation to others' actions.

·   Social Perceptiveness Being aware of others' reactions and understanding why they react as they do.

Desktop Computer Skills

·   Databases Using a computer application to manage large amounts of information, including creating and editing simple databases, inputting data, retrieving specific records, and creating reports to communicate the information.

·   Navigation Using scroll bars, a mouse, and dialog boxes to work within the computer's operating system. Being able to access and switch between applications and files of interest.

·   Presentations Navigating the Internet to find information, including the ability to open and configure standard browsers; use searches, hypertext references, and transfer protocols; and send and retrieve electronic mail (e-mail).

·   Spreadsheets Using a computer application to enter, manipulate, and format text and numerical data; insert, delete, and manipulate cells, rows, and columns; and create and save worksheets, charts, and graphs.

Tools

·   Mobile phones

o  Smartphones

·   Notebook computers

o  Laptop computers

Technology

·    Data base user interface and query software

·    Calendar and scheduling software

o  Scheduling software

·    Electronic mail software

o  Microsoft Outlook

·    Internet browser software

o  Web browser software

·    Office suite software

o  Microsoft Office