Kelly Science and Clinical FSP is currently seeking a Regional Clinical Research Associate for a long-term engagement in the US with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Fraudulent Applications: All information provided during the application process will be verified. Misrepresentation of credentials, identity fraud, or use of proxy interviewers will result in immediate disqualification and may be reported to appropriate authorities.
Regional Clinical Research Associate
Regional travel flexing up to 75%
 

• To support 1-3 protocols in the cardiovascular/electrophysiology medical device space.
  

• The ideal candidate will have cardiovascular medical device monitoring experience- however, cardiovascular/electrophysiology pharma monitoring experience will be considered.
  

• 3 years of monitoring experience required.
  

• Bachelor’s degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
  

• Candidates must have/ be:In-depth knowledge of FDA regulations and ICH/GCP guidelines.
  

• Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly.
  

• Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams.
  

• Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely.
  

• Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment.
  

• ·Ability to work independently and manage multiple priorities in a dynamic environment.
  

• A well-executed plan for communication with the study teams and sites.
  

• Well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their reports.
  

• In-depth knowledge of FDA regulations and ICH/GCP guidelines.
  

• Candidates must have complex cardiac experience within the past 5 years, preferably in electrophysiology and / or devices.
  Examples provided for reference, not an all-inclusive list: 
  

  • Best– device examples: Ablation catheters, pacemakers, ICDs, LAACs, stents, valves
    

  • Good– pharm examples: Rhythm disorders, myocardial infarction
    

  • Not sufficient: Hypertension, hyperlipidemia
    

  
  

• A plus:
  

  • CRA training or bridge program through a reputable organization / employer
    

  • Clinical background
    

10084408