The Pharmaceutical industry is responsible for bringing in new drugs for the treatment of diseases. For this, it largely depends on clinical studies and trials conducted by clinical research teams that include research associates and other professionals.
A Clinical Research Associate (CRA) runs clinical trials to test the drugs for their effectiveness, risks, and benefits to ensure that they are safe to introduce into the market. They work on trials for existing drugs or new drugs as per the requirement of a pharmaceutical company. CRA could be employed by the pharmaceutical company directly or could be engaged through a Contract Research Organization (CRO) which works for pharmaceutical companies.
Clinical research associates can be engaged through a CRO or any talent outsourcing company then they are called Contract Clinical Research Associates. The contract could be full time engagement or for a specific project which may last from six months to a year. Research associates would be involved at all stages of clinical trials such as site selection, setting up, initiating, conducting, monitoring and closing a trial.
Clinical Research Associates- Duties and Responsibilities
- Developing and writing trial protocols (outlining the purpose and methodology of trial)
- Presenting trial protocols to the steering committee for approval.
- Designing data collection forms or Case Report Formats (CRFs)
- Co-ordinating with ethics committee which oversees the rights, safety, and wellbeing of subjects involved in trial
- Liaison with regulatory authorities for application and approvals
- Identify and assess suitability of trial site
- Co-ordinate with Doctors or Consultants and investigators for conducting the trial
- Set up trial sites in terms of all training of staff and facilities required
- Monitoring trial site with regular visits
- Collect clinical trial documents including CRFs and verify contents
- Accounting for all trial supplies
- Closing trial sites after completion
- Assist in trial technical documentation and archiving
- Prepare final report and manuscripts for publication if required
Requirements for Clinical Research Associates
- A university graduate/post –graduate degree (preferably a science degree)
- Some experience clinical operations with project management and study team management skills. Prior experience is not mandatory for fresher positions.
- Ability to develop good rapport with doctors, subjects and investigators
- Good understanding of drug development process and regulatory requirements
- Ability to deal with unexpected events and incomplete information
- Possess excellent verbal and written communication skills
- A strong analytical and problem-solving ability
- Abilityto pay attention to details
- Capacity to work under stress to meet stringent deadlines
*The median annual Clinical Research AssociateIsalary is $56,378, as of April 27, 2017, with a range usually between $49,594-$62,297. However, this can vary widely depending on a variety of factors. The data is based on the analysis of survey results carried out by Certified Compensation Professionals from several HR departments at companies /industries of all sizes in the United States. Source: salary.com
Job opportunities exist in pharmaceuticals companies and contract research organizations (CROs). Working hours are usually full-time from Monday to Friday. If CRA has a field-based role, they are mostly out visiting doctors, nurses in trial centers or hospitals. In case of the international companies, with trial sites spread across the globe, considerable overseas travel may be involved. The field role involves a lot of travelling.
Clinical Research Associate is a good choice for people who have excellent analytical abilities, love to read and research and like the medical field.