If you want to become a clinical research associate (CRA), you need to begin by first ensuring if this career path is appropriate for you. Are you really interested to be a part of clinical research industry? Can you come across completion in ensuring clinical trials are conducted ethically and safely ? Are you keen in a career that allows you to grow up and take on more responsibilities? If so, then a career as a clinical research associate may be sound suitable for you!
Following is outlined what you will require to succeed in a career as a CRA (clinical research associate). You will also find good information about CRA as a career, such as job duties, job description (JD), a list of prospective employers, salary prospects and much more!
Job Description (JD) Clinical Research Associate
A CRA has an important task within the clinical trial process. He/she has the key responsibility to verify that the safety, rights and well-being of human subjects (patients) are protected and that the reported clinical trial data are accurate, verifiable from source documents and complete. Most importantly, the clinical research associate makes sure that the conduct of the trial is in compliance with the recently approved protocol or amendment(s) protocol, with good clinical practice (GCP), and with applicable regulatory authority requirement. The CRA performs clinical site (hospital) monitoring and manages/ collects clinical research documents, including clinical study protocol, ICFs (Patient Informed Consent Form), CRFs (clinical case report forms), IBs (Investigator Brochure) and clinical trial related documents.
Clinical Research Associate Job Responsibilities
CRA need to ensure safe and right conduct of clinical trials according to ICH-GCP guidelines.
- Maintain current understanding of organization’s SOP (standard operating procedures) and also required sponsor SOPs if applicable.
- CRA required in providing clinical study progress reports to Clinical Trial Manager /Designee periodically.
- CRA must plan & conduct pre-study site evaluation visit with Sr. Clinical Research Associate / Clinical Trial Monitor.
- CRA must conduct clinical site feasibility and also help CTMs in study feasibility.
- CRA Prepare and maintain Clinical Study Files including Trial master files (TMF), Investigator Site File (ISF), Investigator File (IF), study essential documents and regulatory documents etc.
- CRA prepare EC (Ethical committee) document for submission and other tools, templates and documents before clinical site initiation.
- CRA also attend and assist with IM (investigator meeting) in presentations, training materials, logistic preparation, and coordination.
- CRA plan & perform SIV (site initiation visit) with Sr. Clinical Research Associate/CTM
- At the time of site initiation visit (SIV) CRA meet clinical investigators (PI) and their team to make sure that all aspects of the study are understood by the principal investigator and his/her staff, validate the suitability of the EC / IRB & make sure that all records required for the study are complete.
- CRA is also expected to handle clinical central laboratory in regard to issues of site.
- CRA plans, conducts site monitoring visits (SMV) as per study protocol under the supervision of the CTM/Designee.
- CRA keep track of patient recruitment procedure by contacting clinical sites & verify patient screening & enrollment development.
- Assessment of subjects (patients) for study protocol compliance though SDV (source data verification).
- CRA monitor patient Informed Consent progression for clinical study.
- CRA examine on-site CRFs (Case Report Forms) aligned with source documents for data authentication.
- CRA make out the discrepancies in the case report forms against the source documents, resolve them and after that take away the CRFs.
- Periodic follow up with clinical site for resolution of DCFs or any queries.
- Adverse event/serious adverse event AE/SAE reporting and follow up with the concern departments.
- CRA make sure appropriate Investigational Product (IP) answerability at site.
- CRA plan and conduct site close out visit (SCV) and make sure that collection of all clinical study data are complete.
- CRA prepare the applicable site visit reports and follow up letter.
- Subsequent to study completion, make sure that investigational products (IP) of the study are returned to the CRO / sponsor.
Education and Training Required to Become a Clinical Research Associate (CRA)
To get an entry-level job in clinical research, you are required to be an undergraduate degree in life sciences, nursing, biotech or medical sciences and a diploma or certification in clinical research from a reputed institute. It is suggested to have a graduate degree as it can enable one to stand eligible for much more senior level positions, a higher pay grades and achieve benefits over other individuals.
It is sometimes feasible to break into this profession from the administrative side as well without having formal education and learning in the above-mentioned areas; however it demands a significant amount of administrative knowledge in clinical research, and perhaps further qualifications.
Skills Required to Become a Clinical Research Associate (CRA)
In order to turn out to be an efficient clinical research associate, you need to have a certain set of skills. Being efficient in this skill set could allow you to move into more responsibilities and better pay. These skills include:
- Understanding of the clinical research, healthcare system, healthcare regulation and procedures for regulating the growth of healthcare products.
- Should be capable to prepare a clinical development plan.
- Should be capable to make sure clinical trial data is reliable and correct and that the legal rights, sincerity and privacy of trial subjects are safeguarded.
- Require to have a complete knowing of liabilities and responsibilities of performing study with human subjects.
- Should have a knowing of the challenges and restrictions of implementing and retaining databases.
Who Employs Clinical Research Associates (CRA)?
- Clinical research associates (CRA) are generally employed by the following kinds of organizations:
- Contract Research Organization (CRO)
- Biotech companies
- Pharmaceutical companies
- Self-employment (Freelance basis)
Clinical Research Associate (CRA) Salary
The salary ranges of clinical research associates can differ based upon a variety of aspects, which include their level of education and learning, their amount of experience, the place of work, whether they have done any clinical research diploma/ training/ certification or not, the stage of funding for their project, organization HR policy and several others.
The fact is that there is no unique salary data for clinical research associates in many countries such as Canada or the United States, India. We can on the other hand, get an excellent idea of their salary level by looking at the CRA job posting posted by various organization in their website, pay scale grading organization and many reputed job portals.
|Country||Annual Average Clinical Research Associate Salary|
|USA and Canada||$ 47,000|
|United Kingdom||£ 28706|
|South Africa||R 296,566|
Career Growth for Clinical Research Associates (CRA)
Despite the fact that career structures vary from organization to organization, you can usually go up from an entry-level position in clinical research such as Jr. research associate, clinical trial administrator pretty quickly, based upon aspects such as the expertise of your skill set, your level of commitment, your prior experience, your level of training & education, and several others. Increased responsibilities may possibly include tasks such as:
- Doing the job on pre-trial procedures.
- Participating investigator meetings (IM).
- Coordinating with ethics committee (EC).
- Coordinating with regulatory authority.
- Monitoring and training Jr. staff.
- Project management.
James Lind Institute offers multiple self paced online training programs that can help you become a Clinical Research Associate. To know more about the training programs available please click herehttp://www.jliedu.com/programs