Clinical Research Professional Certificate Program Fact Sheet

 Quick Facts

Nature of the Work

A CRP is a professional who, irrespective of job title, supervises, monitors, and supports the administration and progress of a clinical trial on behalf of a sponsor, whether from external monitoring (Clinical Research Associate) or in-house execution of a trial (Clinical Research Coordinator, Data Manager, or Regulatory Affairs Specialist, for example). The sponsor, whose intent is the research of pharmaceuticals, biologics or devices, may employ these individuals either directly or indirectly via Contract Research Organizations (CROs) or independent consultants/ contractors in physicians’ offices, groups, clinics, or research hospitals. Clinical Research Coordinators work for Principal Investigators (typically physicians) and interact with study subjects, administering treatments, collecting data, evaluating for adverse effects, protecting the rights of the subjects as required by federal and local laws, and collecting and reporting data to the sponsor. Clinical Research Associates (Monitors) are external auditors working for the sponsor who monitor the work of the research site and inspect for the quality of collected data.

Duty Description

Conduct basic project activities including program development planning, preparing, submitting and amending the protocol as necessary and assisting with resource planning and management.

Complete pre-study activities such as assisting with informed consent documents and procedures, training of staff, administrative services like the collection and submission of forms and collaboration with database management.

Conduct study activities such as planning and conducting investigators meetings, prepare for site initiation visits, prepare and conduct audits and inspections and complete study reports as assigned.

Conduct study follow-up activities such as conducting ongoing monitoring visits, assisting with final reconciliation of databases and information, ensuring end of study reports and activities are completed and prepare data for long term storage.

Prepare presentations of study data for national meetings and prepare data for publication in professional journals.

Occupational Trends

Prospects for positions as Clinical Research Coordinators (CRCs), Clinical Research Data Managers, and Clinical Research Regulatory Specialists are good, and continue to increase in demand over the past several years as federal regulatory oversight and the need for new medications and medical devices has increased. Local and national employment opportunities remain very good. Recently pharmaceutical companies have begun out sourcing the site monitoring function of clinical trials and that has caused an increase in hiring of Clinical Research Associates (Monitors) by Contract Research Organizations (CROs). Most positions are not advertised publically, but are sought through local chapters of trade organizations (ACRP and SoCRA) and by word-of-mouth through active practitioners. Openings for CRPs are expected to increase in the next few years due to increased demand for new drugs and medical devices, an increases in required federal oversight.

Job Outlook

Employment of clinical research professionals is projected to continue to grow 36.4% through the year 2022. According to INDEED.com, there are currently 89,217 clinical research positions posted nationwide. Georgia has about 10% of these varying positions available statewide. Best job availability will be for those who may be willing to relocate.

Earnings

The entry-level research assistant will average $37,980 per year with the diploma or associates degree in healthcare and salary will continue to rise for those with higher degrees beginning the program to $49,084 on average for those graduates.

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