2019-2020 Course Catalog and Student Handbook 
    
    Nov 17, 2019  
2019-2020 Course Catalog and Student Handbook

Clinical Research Professional Certificate Program Fact Sheet


What is Clinical Research? The term “clinical research” refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.
Length of Program 1.5 semesters; Program courses must be taken in sequence within the prescribed time frame.
Semester Program Begins Fall semester and spring semester (online)
Minimum Age Requirement 18 years of age at the start of program
Application Process
  1. Apply to Gwinnett Technical College at GwinnettTech.edu, submit all transcripts from high school and previous college work, and take the ACCUPLACER test, if required. Students must be accepted into Gwinnett Technical College prior to applying to a program of study.
Program Application Process
  1. All applicants are required to submit a program advisement form. Forms are available online at http://www.GwinnettTech.edu/enrollment/forms-documents/
 
  • Fall application deadline: June 1
  • Spring application deadline: October 10
Program Requirements

1. Program director approval
2. In order to be eligible for admission, the applicant must meet one of the following criteria:

  • Current certification or licensure in a health care field.
  • A diploma/degree in science or a health care field.
For more information, contact: Michelle Forthofer, RN, BSN, program director, MForthofer@GwinnettTech.edu, 678.226.6406.
Kim Smith, program support specialist, KimberlySmith@GwinnettTech.edu, 678-226-6966.

Information Sessions

Lawrenceville Campus: 4th Tuesday of each month at 4 p.m. Building 200, Room 339
Alpharetta-North Fulton Campus: 1st Tuesday of every month from 10 a.m. - 2 p.m. by appointment only

Please contact Kim Smith (KimberlySmith@GwinnettTech.edu) to make an appointment


Quick Facts

2019 Median Pay (depending on existing degree)          $37,980 - $49,084
Entry level education needed          Diploma or Associate Degree in Healthcare
Number of jobs available nationwide          89,217 in 2019
  Job growth 2012 - 2022          36.4%

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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