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Clinical Research Associate Job Description
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When clinical trials are being performed on volunteers or patients to determine whether new drugs or treatment regimens are safe for human use, a clinical research associate performs an important role by observing and monitoring the effects of the procedures and compiling unambiguous reports on the findings.
Clinical Research Associate Job Duties:
If you have a strong interest in medicine and research and would like to be a part of the process that aids in bringing new and effective drugs to ailing and diseased patients, a job as a clinical research associate would be perfect for you. Besides the clinical research industry, jobs are also frequently found in pharmaceutical and medical device companies.
Duties are:
1) Ensuring safe and legally correct conduct during the trial procedures.
2) Confirming that all the personnel involved in the procedures have the required qualifications and experience.
3) Coordinating the efforts of the research team.
4) Making sure that the process is being carried out as per the particular project’s standard operating procedure (SOP).
5) Acting as a reference point between the investigators and the sponsors of the trial.
6) Verifying the accuracy of data.
7) Generating precise reports.
8) Recording and reporting any deviations from established protocol.
9) Travelling to various sites if required, when research is being conducted at different venues.
Clinical Research Associate Knowledge and Skills:
1) Good report writing skills are essential to write accurate reports on findings.
2) Superior written and oral skills are vital to discuss and communicate complex information with sponsors, team members and volunteers.
3) Strong team building and management skills are required to foster a healthy atmosphere and resolve conflicts when they arise.
4) Ability to make quick decisions in emergency or unusual situations.
Clinical Research Associate Educational Qualifications and Experience:
1) A Master or Bachelor’s degree in science, usually in a bio-medical field. In some cases a Registered Nurse qualification may be required.
2) Experience of 1 – 4 years is the norm.
3) Certifications often preferred and sometimes insisted upon include CCRA/ CCRP/CCRC (Certified Clinical Research Associate, Professional or Coordinator).
4) Thorough knowledge of International Conference on Harmonisation (ICH) / WHO Good Clinical Practice (GCP), Code of Federal Regulations (CFR) guidelines and regulatory requirements
5) Ability to work with Clinical Trial Management System and Clinical Data Management software.
Clinical Research Associate Salary and Benefits:
1) Annual average clinical research associate salaries range between $45,000 and $70,000
2) Benefits usually offered include paid vacation, paid sick leave, 401(k), education tuition reimbursement and a flexible work schedule
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