Wednesday, May 25, 2011

Clinical Research Associate (CRA) Job, Resposiblity, Qualification & Salary

Clinical Research Associate: CRA has an important task within the clinical trial process. He or she has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. Most importantly, the CRA makes sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement. There are various levels at which a CRA can work. Examples of this are Junior, level 1 and 2 (also known as CRA Senior or Lead CRA). These differing levels determine the tasks and responsibilities to be carried out, and are often experience dependent.
Responsibilities of CRA 1:
  • Perform routine site visits, including pre-study, initiation, interim, and closeout visits. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements and assurance of good site performance. This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.
  • Assist investigator meeting including preparation, liaison, presentations, problem resolutions, and follow up.
  •  Ensure timely submission of protocol / consent documents for EC/IRB approval.
  •  Maintain all files and documentation pertaining to studies.
  • Motivate investigators in order to achieve recruitment targets.
  • Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
  • Report to Research project team, client, and site personnel any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines. Significant issues noted must be reported to appropriate personnel immediately.
  •  Maintain eClinical or alternative project tracking system of subject and site information.
  •  Serve as back-up for Regional Manager, Clinical Operations when required.
  •  Provide training for colleagues on clinical, regulatory, administrative, and company procedures and processes.
  •  Participate in feasibility studies.
  •  Assist with company’s quality control initiative.
  •  Present study materials at Investigator/study launch meetings when required.
  •  Support project management team with assessment of workload and site assignments within the project team.
  •  Assist project management team with review of monitoring reports and study documents when required.
  •  Participate in the interview process of potential candidates when required.
  •  Participate in company-required training programs.
  •  Perform necessary administrative functions (e.g., tracking of expense reports, time and attendance).
  •  Maintain home office (e.g., procurement of office supplies, submission of documents).
  •  Perform other duties as assigned.
  • Bachelor’s level degree in life sciences, science related area, pharmacy, nursing, Medical, Dental, Allied Health Science, Master degree is preferred.  
  • Clinical monitoring experience
  • Strong knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements
  • Proven ability to work independently in a fast-paced environment
  • Strong communication, interpersonal, and organizational skills
  • Must demonstrate good computer skills
  • Ability to provide clear direction and guidance to others.
  • Position requires approximately 60% travel (up to 80% during peak times).

There is high demand for trained professionals in this field. Its a novel profession and pay package is very impressive which depends on candidate qualification and recruitment company. At entry level candidate can expect of around three to four lakhs or more per annum in INR. Salary is directly proportional to the experience.

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