Universal Clinical Research Coordinator (CRC) Training
A Clinical Research Associate is a medical science professional who conducts medical research and monitors clinical trials. They determine the effectiveness of new and existing drugs or biomedical and health care devices and confirms whether they are safe to release into the market for consumers.
Clinical research associates (CRAs) act as a liaison between the trial sponsor and the hospitals or clinics conducting the study in some or all stages of the clinical trial process. Contract research organizations that work with one or many pharmaceutical companies typically employ these professionals.
In this training, we explore the crucial role of a Clinical Research Associate (CRA). You will learn the fundamentals of the CRA role and how they work to ensure the safety and efficacy of clinical trials. You will gain an understanding of who the stakeholders are that a CRA works with and how to constructively work together at an investigational site. You will also learn how a CRC can support a CRA by providing critical medical and scientific knowledge, and by building relationships with key stakeholders. By working together with the research team, the CRA can help to bring new treatments to patients more quickly and safely.
A Clinical Research Associate is a medical science professional who conducts medical research and monitors clinical trials. They determine the effectiveness of new and existing drugs or biomedical and health care devices and
confirms whether they are safe to release into the market for consumers.
Clinical research associates (CRAs) act as a liaison between the trial sponsor and the hospitals or clinics conducting the study in some or all stages of the clinical trial process. Contract research organizations that work with one or many pharmaceutical companies typically employ these professionals.
In this training, we explore the crucial role of a Clinical Research Associate (CRA). You will learn the fundamentals of the CRA role and how they work to ensure the safety and efficacy of clinical trials. You will gain an understanding of who the stakeholders are that a CRA works with and how to constructively work together at an investigational site. You will also learn how a CRC can support a CRA by providing critical medical and scientific knowledge, and by building relationships with key stakeholders. By working together with the research team, the CRA can help to bring new treatments to patients more quickly and safely.
Some primary responsibilities for clinical research associates at clinical trial sites and sponsor locations includes:
Overseeing clinical trials on behalf of clinical research institutes, pharmaceutical companies or government agencies. Developing, outlining and writing clinical trial protocols and ensuring compliance with local standard operating procedures and good clinical practice guidelines. Other common duties may include but not limited to the following:
- Identifying, evaluating and setting up clinical trial sites for conducting research studies
- Designing, ordering, tracking and managing clinical trial supplies
- Ensuring all trial centers have sufficient material availability
- Training of staff at clinical trial sites on industry standards, protocol requirements and documentation
- Liaising with ethics committees and regulatory authorities to safeguard study participants' rights, safety and general well-being
- Protecting study participants' confidentiality and recording their personal information and data
- Designing data collection forms
- Leading and overseeing the generation of documentation and records
- Monitoring the clinical trial throughout its duration
- Collecting completed case report forms from hospitals and general practices
- Discussing the results of the clinical trial with a medical statistician
- Presenting the results of the clinical trial to the study steering committee
- Preparing final reports and potentially, manuscripts for publication
- Essential Regulatory Documents
- Food and Drug Administration (FDA) Regulations
- Good Clinical Practices
- Investigator Responsibilities
- Electronic Data Capture (EDC)
- Clinical Trial Management Systems (CTMS & eTMF)
- The Informed Consent Form (ICF)
- Site Qualification Visit (SQV)
- Site Initiation Visit (SIV)
- Routine Monitoring Visits (RMV)
- Site close out Visit (COV).
You will learn about the daily activities of a Clinical Project Manager (CPM), Clinical Trial Assistant (CTA), Clinical Data Assistant (CDA), Clinical Operations Specialist (COS) on how they collaborate as a team in clinical trials to ensure that new treatments are brought to patients speedily and safely too.
Why Be A Clinical Research Associate?
CRAs are always in high demand and the career can be quite rewarding. There are however, very few opportunities out there for individuals without adequate prerequisite knowledge or industry experience. The minimum requirements for an individual to become a CRA are as follows:
- Prior industry experience is typically required
- Must have at least a Bachelor’s degree (foreign degrees are acceptable; degrees do not have to be science related)
- Must have a working knowledge of the fundamental principles and training in clinical research.