Senior Clinical Research Associate - East Coast

Kelly Science and Clinical FSP is currently seeking a Senior Clinical Research Associate for a long-term engagement in the US with one of our Global Pharmaceutical 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 will be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Summary:
This individual will be responsible for managing clinical activities at study sites conducting studies for the Medical Devices group, as well as, fostering strong, productive relationships with colleagues within the Medical Devices Group.  

Responsibilities:
Responsible for managing clinical study activities for multiple sites in single or several clinical projects. Oversees performance of appointed study sites, conducting company initiated clinical studies.  Responsible for the site visits, monitoring, communication, and deliverables for the assigned study sites.  Serves as a member of the clinical study team and is the liaison between the clinical study team and study site personnel for the specific clinical projects.  
 

Clinical Study Site Management Tasks: 

• Verify safety and well being of study subjects are maintained for assigned study sites. 

• Support the operational execution of clinical trials and ensure collection of high quality, substantiated data. 

• Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements. 

  
  

• Accountable for study site performance, and providing high quality data according to overall project timeline.   
  

• Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Responds to problems and assists in implementing corrective and preventive actions, if required. 
  

• Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures. 

  
  

• Responsible for supporting patient recruitment and retention activities. 

  
  

• Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures. 

  
  

• Assists with internal communication of important clinical data and events.  

  
  

• Support organization of Investigator and other study training meetings, if required. 

  
  

• Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders. 

  
  

• Understand business value of clinical projects and balances overall business objectives and functional needs. 

  
  

• May be involved in other tasks to support Clinical Operations and Operating Company as needed. 

  
  

• Support the implementation of new clinical systems/processes. 

  
  

• Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed. 

  
  

• Previous clinical research experience required. 

  
  

• Previous medical device monitoring or equivalent experience required. 

  
  

• Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products. 

  
  

• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).

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