Clinical Specialist

Position: Clinical Specialist
Location: Maple Grove, MN 55311
Duration – 6+ months Contract 
Job Code - PHHJP00011087 


• Work with Project Manager and study team in study start up activities 
• Assists Project Manager in oversight of Contract Research Organizations (CRO) 
• Assists with successful conduct of assigned studies consistent with the Clinical Strategy. This includes interfacing with representatives from key functional groups including Field Monitoring, Quality Affairs, Product Development, Manufacturing, Sales, Marketing, Customer Service, Regulatory Affairs, R&D, and European Clinical Groups 
• Assists in preparation of study related material and training materials 
• Works with Clinical Project Manager to develop plan to ensure device accountability for clinical sites 
• Assists Clinical Field Specialists and Clinical Project Manager in obtaining all necessary documents from clinical sites prior to site initiation and updating documents as determined by needs and length of trial 
• Reviews and verifies adequacy of center activation documentation 
• Works with the monitor and participating centers to ensure compliance with the protocol and regulations and the timely receipts of accurate data and other required study documents 
• Reviews clinical data/information and oversees data correction 
• Comply with applicable FDA and international regulatory laws/standards, company-wide and departmental Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) 

Experience: 3-5 years professional experience. 

Education: Bachelor's Degree or equivalent unless otherwise specified. 

Required Knowledge and Skills: 
• Cardiovascular experience preferred, but not required 
• Ability to work independently and as part of a team 
• High attention to detail and accuracy 
• Advanced written and oral communications skills 
• Able to manage multiple tasks 
• Proficient knowledge of medical terminology 
• Expertise with GCP and regulatory compliance guidelines for clinical trials 
• Good problem-solving skills 
• Knowledge of clinical and outcomes research study design

Venkatesh Aithal
Sr. Technical Recruiter
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark , CA 94560  //

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