The CRA Training Institute | Preparing Professionals for Clinical Research Since 1989

FAQs

FAQ: What is a CRA?

A Clinical Research Associate (CRA) can also be called a Monitor, a Clinical Monitor, a Trial Monitor or a Medical Monitor. The title will vary from company to company. The job description will be the same. A CRA is an individual employed by a pharmaceutical or medical device manufacturer, by a contract research organization (CRO) usually acting on a sponsor's behalf or by an academic institute conducting clinical trials.

Federal Regulations require that sponsors of clinical studies select individuals who are qualified by training and/or experience to monitor their studies per 21 CFR 312.53 (d). ICH Guidelines 5.18.2 (b) also states that Monitors be appropriately trained and their qualifications documented.

Our online program provides this required training.

The major responsibilities of a CRA are:

To analyze and evaluate clinical data, to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA.
Assure the protection of the rights, safety and well being of human study subjects.
Identify, help in the study site selection process, initiate, and eventually close out clinical study sites.
To monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately.
To make certain that the scientific integrity of the data collected is protected and verified.
Assure that adverse events are correctly documented and reported.
Review all case report forms and compare them to source documents.

This online training certificate program teaches you all the responsibilities of the CRA.

FAQ: How long will it take to complete your online training program?

On average, it will take most people 2 - 3 months (assumes 8 - 10 hours study per week) to fully understand and learn the material presented and complete the various required assignments. You are however free to study at your own pace and can complete the program sooner or later depending on your personal schedule and time allocated to study.

FAQ: What are CRA Salaries?

All salary information will depend on experience and the needs of the hiring companies. Typical starting salaries for new CRAs are around $50,000 and higher. Salaries quickly rise with experience. With a couple years experience, you can expect to earn between $60,000 and $75,000. Some of the companies pay up to $120,000 and supply their CRAs with a company car.

FAQ: Do you guarantee that I will obtain a CRA position after taking your CRA Certificate program?

No, we can not guarantee anyone a position as a CRA upon completion of our program. Since it is out of their control, providers of training programs do not guarantee anyone a job upon successful completion of their program. If you were referred to us by a potential recruiter or employer, chances are that they will be looking to hire you upon successful completion of the program.

We do however research, collate and maintain a very comprehensive and up-to-date Jobs Database of CRA positions from pharmaceutical manufacturers, recruiters and CROs who are looking for CRAs.

FAQ: What is a CRO?

An organization (commercial, academic, or other) contracted by the pharmaceutical manufacturer/sponsor to perform one or more of a sponsor's clinical trial-related activities. There are hundreds of large and small CROs, all of them employing CRAs.

FAQ: What is the typical background of a CRA?

Usually, the CRA will have a health care or science background. About 40% of CRAs have a Nursing background, either BSN or RN. Other types of health care/science experience includes medical technologist, pharmacist, or physical therapist.

FAQ: Will I have to relocate if offered a job as a CRA?

It will depend on the individual company, university/academic institution or Contract Research Organization where you are hired. A CRA can either work from the company headquarters, a branch location specifically for CRAs, or from their own home.

FAQ: What other positions in the pharmaceutical industry can an experienced CRA hope to move into?

Clinical Research jobs/positions include: Clinical Research Coordinator (CRC), CRA Manager, Project Manager, Research & Development Project Managers, GCP QA/QC Auditors, Data Managers/Biostatisticians, Regulatory Affairs & Compliance Professionals, Safety Managers, Corporate Managers, Clinical Research Trainers, Clinical Site Managers and Business Development Professionals

FAQ: Who does the CRA interact with while on the job?

The CRA will work and Interact with internal/sponsor company personnel working in clinical trials, e.g. Clinical Study Managers, other CRA's, Drug Safety, Regulatory Affairs, Quality Assurance, Medical Writers, Statisticians, Data Management, etc. External interactions can include people from the FDA, a Contract Research Organization, the Hospital Pharmacy Department, Study site staff particularly the Investigator and Study Coordinator.

FAQ: How current is the information in this certificate program?

Our program is updated when changes in the HIPAA privacy regulations, the FDA Code of Federal Regulations, the ICH Guidelines and the Center for Drug Evaluation and Research (CDER) regarding the monitoring of clinical trials are published by the regulatory organization.

FAQ: Can I get a job without being Certified by SoCRA or ACRP?

Yes, absolutely. These organizations offer "Certification" for CRAs. They all require that the you have at least one or two years of on the job experience as a CRA before you can take a "certification" test. Then the CRA needs to pay for and pass a certification test/exam. Most CRAs are not "Certified". This is a confusing and debated issue. Clinical Research is not a licensed profession. Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs) do not need to be "certified" in order to get a job or do their job.