Updated on September 30, 2022
Overview:
Medical research relies heavily on Clinical Trials and for running successful Clinical Trials, a team of diverse and skilled professionals is a must. A Clinical Research Assistant is an integral part of a Clinical Trial team. Clinical Trials and a skilled medical team enable the medical community to understand conditions better, lessen the burden of sickness, and improve the general health of communities.
A new drug or medical device’s safety, effectiveness, dependability, and side effects are all thoroughly examined in Clinical Trials. Additionally, Clinical Trials provide patients with potentially unavailable market-based therapy options that are urgently required.
The workforce in a Clinical Trial:
For successful Clinical Trials, it is crucial that individuals from diverse backgrounds take part in Clinical Trials since doing so helps to remove biases, advance social justice, and health equity, and spurs more creativity in the research industry. Depending on the funding at hand, the workforce of a Clinical Trial consists of:
Principal Investigators:
This person often called a Principal Investigator, is in charge of managing every aspect of a clinical research study. They design the study, create a thorough explanation of how it will be carried out, and then submit it for approval to the Institutional Review Board (IRB). This person is also in charge of recruiting participants and ensuring they are aware of their rights and willing to participate. They also oversee the gathering, examination, interpretation, and dissemination of research findings. In the end, the PI is in charge of the entire study.
Clinical Research Coordinator:
A Clinical Research Coordinator’s job is to manage a lot of the tasks of a Clinical study. The recruitment process may involve the Clinical Research Coordinators, who also make sure that participants are aware of the research’s needs and have agreed to participate.
Additionally, Clinical Research Coordinators can arrange research visits and conduct research interviews. To ensure that the study adheres to research regulations, they collaborate with the principal investigator (PI), the research institution, and other parties.
Clinical Research Assistant:
A Clinical Research Assistant (CRA) assists Principal Investigators (PIs) during Clinical Trials that are dedicated to researching novel medications and medical technologies. They must set up the lab, deal with volunteers, collect biological samples or vital signs, and organize data as Clinical Research Assistants. Additionally, they might need to set up work areas. It is their responsibility to help the researchers do solid, moral, and truthful research by offering any assistance they can.
Clinical Physician:
The PI and these physicians collaborate to monitor and treat trial participants. Patients are cared for according to the Clinical Trial’s design, and side effects and responses are assessed and recorded.
Research Nurses:
This team member frequently discusses research specifics with patients, employees, and local healthcare professionals who might refer their patients. Additionally, the individual assists the PI in monitoring for adverse effects and assists with administering the research medications.
Participants:
These people volunteer for a Clinical Trial to help advance medicine.
Job Role of A Clinical Research Assistant:
- Observe Clinical Studies and record activity.
- Ensure that all Clinical Trial protocols are followed.
- Fill up the necessary fields using data from Clinical Research.
- Use a computer, recorder, or scanner to transfer data from paper forms.
- Make spreadsheets with enormous numbers more orderly.
- Observe activities at the clinical site.
- Prepare letters, reports, or presentation materials based on your findings.
- Create trial informed consent forms.
- Examine research studies.
What Skills Are Required To Be A Clinical Research Assistant?
Clinical Research Assistants must possess a specific set of abilities in order to be hired and succeed in their positions. Whether you already have these talents or not, you can learn and develop them by enrolling in online classes or working. You’ll need to have some key abilities, such as:
- Administrative abilities, including the capacity to accurately record crucial information.
- IT and computer competencies, including management of databases and systems.
- Both oral and written communication abilities.
- Keen observation and attention to detail.
- The ability to coordinate and manage several stakeholders.
- Strong grip on medical terminology, clinical research trials, and the healthcare industry.
What Does A Clinical Research Coordinator Do?
A qualified researcher working with and under the guidance of the Principal Investigator is the Clinical Research Coordinator (CRC). While the CRC supports, organizes, and coordinates daily Clinical Trial operations and plays a crucial role in the execution of the study, the Principal Investigator is ultimately in charge of the clinical trial’s overall design, conduct, and management. With the help of these responsibilities, Clinical Research Coordinator’s job is to collaborate with the PI, department, sponsor, and institution to support and offer direction on the administration of the clinical study’s compliance, financial, personnel, and other related issues.
Job Duties of A Clinical Research Coordinator:
The role of a Clinical Research Coordinator is crucial in the success of a Clinical Trial. The Clinical Research Coordinator job includes:
General Administration:
The clinical Research Coordinator’s job is to coordinate with the Principal Investigator to carry out clinical studies in conformity with federal regulations and the sponsor’s policy and procedures.
- Help PI in preparing materials and tools required to train individuals involved in clinical research. They are also responsible for aligning the documents.
- Coordinate and foster monitoring and audit visits.
- Report any audit findings with the help of the Principal Investigator.
- Report any cases of noncompliance to the concerned regulatory body.
Proposal Preparation:
A Clinical Research Coordinator’s job is to help the PI with study feasibility. Other roles of a Clinical Research Coordinator include:
- Formulating a budget for the Clinical Trial with proper justification for all the costs included.
- Prepare protocol and review
- Establish and organize files
Informed Consent:
The Clinical Research Coordinator’s job is to prepare all documents related to the informed consent procedure. They have to assist the Principal Investigator in the submission of informed consent for review and approval.
Project Closeouts:
Assist the PI in winding up the study with accurate data as per federal regulations and procedures.
Join Our Team:
Revival Research Institute is looking for Clinical Research Assistants and Clinical Research Coordinators to join our growing team and help us advance medicine. With the value and dedication, you may bring, we aim to make healthcare accessible to all.
