The specific duties assigned to the  Senior Clinical Research Associate include the following:

• 
  
  As a member of the clinical project team, provides CRO oversight for OPDC managed clinical trials. This includes and is not limited to planning, organizing, communicating, and implementing study objectives for study protocols.
  
  
• 
  
  Participates in clinical team meetings; leads discussion on assigned protocol(s).
  
  
• 
  
  Prepares a variety of documents including protocol, CRF, informed consent form, operations manual, and other documentation required for the conduct of a clinical trial.
  
  
• 
  
  Identifies potential investigators. Conducts and/or reviews pre-study site visits to assure adequacy of site, investigators, and research staff in accordance with SOPs and relevant regulations/guidelines. Recommends acceptable sites to study and management teams.
  
  
• 
  
  Manages day-to-day clinical operations of assigned protocol(s), including management of vendors (e.g., CRO, central lab, sites, SMOs) and coordination of team member activities.
  
  
• 
  
  Initiates the development of a template site budget for management review and approval, and negotiates budget with sites.
  
  
• 
  
  Participates in conducting investigator meetings, including advance preparation, presentations, problem resolution, and follow-up.
  
  
• 
  
  Performs initiation, interim and close-out site visits in accordance with SOPs when applicable.
  
  
• 
  
  Takes a lead role, under supervision of Clinical Manager, to develop comprehensive subject recruitment strategies and monitors enrollment to assure milestones are met.
  
  
• 
  
   Identifies, analyzes, and reports serious compliance issues, and develops action plans for approval by management. May conduct monitoring or accompanied oversight visits to resolve difficult study conduct issues.
  
  
• 
  
  Ensures continual availability, at each site, of clinical and non-clinical supplies necessary to meet study requirements.
  
  
• 
  
  Reviews tables, listings, and study reports for assigned protocol(s).
  
  
• 
  
  Reviews data listings, manages process, and facilitates data review from all CROs. Tracks all decisions and items that come out for follow-up. Coordinates and ensures that all paper and/or electronic study related documents are appropriately filed for submission and inspection purposes.
  
  
• 
  
  Trains clinical site personnel on the fundamentals of clinical trial management and regulatory requirements. Provides coaching and mentoring to peers as requested.
  
  
• 
  
  Identifies and contributes to the resolution of project issues affecting the clinical conduct of the trial. 
  
  
• 
  
   Anticipates study conduct issues and assists in developing contingency plans prior to study initiation and throughout the life of the trial.
  
  
• 
  
  Conducts oversight visits of CROs throughout the life of the trial and in preparation for inspection and/or achieve.
  
  
• 
  
  Performs other duties as assigned, including continuing to successfully perform functional responsibilities of CRAs.

The successful candidate must meet the following minimum requirements:

• 
  
  Bachelors degree in a health science field or nursing degree
  
  
• Minimum of 5 years of experience in the pharmaceutical industry and 4 years of clinical trial and monitoring experience.
  
• 
  
  Requires comprehensive knowledge of the pharmaceutical clinical development process and applicable regulations and guidelines.
  
  
• 
  
  Thorough knowledge of study SOPs and vendor SOWs.
  
  
• 
  
  Good working knowledge of medical terminology, physiology, and pharmacology in multiple therapeutic areas.
  
  
• 
  
  Solid understanding of the roles and responsibilities of all functional areas in the extended project team.
  
  
• 
  
  Knowledge of GCP/ICH and applicable regulatory requirements.
  
  
• 
  
  Strong communication, organizational and planning skills.
  
  
• 
  
  Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
  
  
• 
  
  Good understanding of CRA-related software, e.g., eCRF, IVRS.
  
  
• 
  
  Strong problem solving and analytical skills.
  
  
• 
  
  Ability to travel 25-30% of the time.

We offer a competitive compensation and benefits package plus a positive work environment, which encourages personal growth and achievement.

For immediate consideration, qualified candidates should apply online at https://careers.otsuka-us.com/OA_HTML/IrcVisitor.jsp   Enter 09-079 for keyword search. 

Otsuka is an Equal Opportunity Employer.