General Summary:

Under the direction of the Director of Clinical Research, this position is responsible for monitoring and management of the Medacta USA (MUSA) routine clinical trial activities. The role is responsible for ensuring that of 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 company’s key areas of focus are orthopedic medical devices in hip, knee, spine, shoulder, and sports medicine applications; therefore, the candidate should have appropriate experience in some, if not all of these areas.

 

Other duties and responsibilities include collaboration with MUSA compliance, research and development, marketing and finance.

Principal Duties and Responsibilities:

Clinical Research

 

Ensure that all clinical trials are conducted in compliance with the applicable Codes of Federal Regulations (CFR), ICH/GCP, Declaration of Helsinki, the Belmont report, other local regulations, and approved Standard Operating Procedures (SOPs).

 

Specific responsibilities include:

 

·         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;

·         Perform on-site and remote monitoring and/or auditing of investigative sites, CROs, and MUSA study files;

·         Management and training of contract research organizations (CRO) and vendors involved in clinical trials, under the direction of the head of Clinical Research.

·         Coordination of study start-up and closure processes, including IRB/EC submissions/approvals, investigator recruitment, site qualification visits, site initiation visits, and site closeout visits.

·         Provide training and guidance to Principal Investigator and site staff regarding compliance with research regulations and guidelines, the clinical protocol, and data collection requirements.

·         Develop, review, support, and deliver presentations for clinical meetings.

·         Management 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.

·         Maintain and update, as necessary, clinical SOPs in compliance with Quality Assurance requirements and FDA regulations.

·         Manage clinical shipments, supply inventory, and destruction according to SOPs and regulations.

·         Responsible for ensuring that all CRFs are received and resultant site payments are reviewed and requested.

·         Provide clinical status updates to head of Clinical Research.

·         Effective training, delegation and follow-up with other team members to ensure quality and timely completion of required tasks.

·         Conduct travel according to company policy, which is expected to be between 40-50% but may fluctuate depending on project needs.

 

Education & Knowledge, Skills &Abilities:

 
Education & Knowledge: 

·         5+ years of clinical research experience preferred including clinical monitoring.

·         Orthopedic experience preferred

·         Certified clinical research professional preferred.

·         Knowledge of ICH GCP guidelines, FDA regulations and IRB policies

·         Undergraduate degree minimum, preferably with technical or scientific coursework

 

Skills & Abilities:

·         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 handle multiple tasks concurrently.

·         Excellent time management skills.