Clinical Specialist

Clinical Operations Research Triangle Park, North Carolina


Description

Position at Premier Research Group Limited

Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. 

We’re looking for a talented and energetic Clinical Specialist to join our team! 

Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. 

Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

 What you’ll be doing:

  • Manage administrative support and tasks for the Clinical Management Team, including eTMF document filing, essential document management, MVR package preparation, project tracking and study site point of contact for designated project team; prepare study documents at the direction and oversight of the Clinical Lead
  • Attend project team meetings, prepare meeting agendas and minutes, and maintain action item lists from meetings
  • Create and maintain active study-level and site-level study files, including Trial Master File according to Premier-Research or client SOPs
  • Essential document oversight and management; start up to close out
  • Maintain study enrollment tracking and study status spreadsheets
  • Distribute study materials to investigator sites, Sponsors and team members
  • Prepare documents for and distribute various investigator and operational guidelines and training manuals
  • Assists in preparation for investigator and other project specific meetings and client meetings
  • May assist with protocol deviation tracking and adverse event reporting, if required
  • May assist CRAs with in-house activities such as data backlog review, Action Item and follow up tracking, MVR package preparation and site management communications; may accompany CRAs on occasional site visits, if required 
  • Support the Start-Up Manager in the feasibility process and in the submissions to Ethics Committees and Competent Authorities
  • Communicate via electronic mail acknowledging and sending correspondence in a professional, timely manner

 

You’ll need this to be considered:

  • Bachelors’ degree (BS, BA, or RN equivalent) in a biological or science-related field preferred
  • Prior experience as a Clinical Specialist (in-house CRA, CTA) preferable
  • Excellent time management skills and organizational and administration skills and the ability to plan and prioritize own work without close supervision to meet deadlines
  • Maintains a positive, results orientated work environment a positive “can do” attitude and someone who is deeply committed to Premier Research’s mission; professional manner and approach to work; accountable, dependable and strong commitment
  • Holds self-accountable for making decisions, managing resources efficiently, achieving and role modelling Premier Research values
  • Excellent team player
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities
  • Strong verbal and written communication skills with a customer service focus in approach to work both internally and externally