Clinical Trial Assistant (CTA):
Who is a Clinical Trial Assistant?
A clinical trial assistant is a person who is responsible for the management of all administrative works related to clinical trials, in every stage of the process. He/she needs to have excellent Word, Excel and PowerPoint skills and should possess the ability of multitasking.
For administering clinical trials, one should have the knowledge of standard operating procedures and good clinical practices. Some of them may need to perform basic medical duties like blood sample taking and blood and lab tests. (1)
A clinical trial assistant need to perform the following tasks:
- Need to organize and archive clinical trial master file documents, which include:
o Clinical study site documents
o Training materials
o Email correspondence
o Other study documents
- Need to generate filing indexes and need to maintain current lists of correspondence
- Have to administer clinical trials following standard operating procedures and good clinical practices
- Have to liaison with independent ethics committees and review boards
- Need to act as the key links between the contract laboratory, study team and study site
- Need to provide logistical support for clinical trials
- Create an agenda
- Have to take minutes of meetings
- Need to assist with purchasing and/or budget activities (2)
How to Become a Clinical Trial Assistant?
The standard educational requirement for a clinical trial assistant is at least a health science associate degree, although an increasing number of employers require only a bachelor's degree. CTAs typically have nursing, pharmacy and health care management or life sciences research academic backgrounds. Statistics classes and lab classes are also necessary for CTAs.
Administrative and Computer Skills:
CTAs need to have excellent proficiency in software applications such as Word, Excel and PowerPoint. Good verbal and written communication skills are also needed for a CTA in addition to the capacity to do multitasking. Experience in health insurance and/or medical office management would be of great value.
Clinical trials would have large amount of data and hence, CTAs need to have strong database skills. They need to maintain and update site demographics on computer databases. They also have to retrieve data and need to answer questions pertaining to certain databases. CTAs might need to log in received clinical research forms and transfer the data from the forms into the database. Sometimes, senior CTAs are assigned the task of trial document control, which requires maintaining master files and version control. (2)
In the United States:
As a clinical trial assistant in the United States, you might expect a median salary of $51,077 annually. The duration of the career is the prime factor which affects the pay of this group, followed by geographical location.
The average salary earned by a clinical trial assistant in India is 232,000 INR annually. (3), (9)
Clinical Trial Coordinator (CTC):
Who is a Clinical Trial Coordinator?
A clinical trial coordinator is a person who conducts clinical trials for the medical world. He/she is responsible for conducting these trials in an ethical manner using good clinical practices. They are the organizers in research labs. They ensure that quality clinical trials are completed with comfortable subjects, accurate reports, and organized information. (4)
As a clinical trial coordinator, you need to:
- Work under the direction of a medical researcher or scientist
- Use questionnaires and interviews, media outlets for screening and recruiting participants for research
- Take care of staff recruitment and education regarding the length, design, and other aspects of the research study.
- Schedule the experiments and tests
- Ensure all samples get to the labs as required
- Monitor the study's data collection process and file necessary reports with regard to the progress of the study
- Review and collect data for various aspects of the study to check for accuracy
- Need to identify and suggest solutions for data collection problems during the trial
- Work closely with researchers in order to help reviewing and developing study protocols so that compliance with standards are followed strictly
- Manage payroll
- Provide recommendations to keep the study within budget
- Work together with sponsors of the trial in order to extend funding or discuss with potential sponsors
- Maintain staff schedules
- Work directly with participants, schedule tests or dispense medication for pharmaceutical trials
- Educate families about the potential pitfalls and other details of medical research projects
- Collect the final data and ensure that the reports contain the information required by different agencies
- Collect, sort, and handover information as required to a medical writer who creates a final manuscript regarding the study's findings (5)
How to become a Clinical Trial Coordinator?
The qualifications required to become a clinical trial coordinator may differ with employer. However, aspiring clinical trial coordinators need to have clinical knowledge and experience, because of the medical nature of the job. Having a degree in a clinical field, such as nursing is a great way to start off as a clinical trial coordinator.
Graduates with a Bachelor of Science (entry-level jobs) or a Master of Science (jobs with more responsibility) in subjects such as chemistry, biology, and biochemistry will be well prepared intellectually for a career as a clinical trial coordinator. Graduates from any of the aforementioned fields may also need to pursue a certificate course or diploma in clinical research, as these programs focus on providing students with skills in practical areas of clinical research. (6)
In the United States:
The average annual salary of a clinical trial coordinator is $132,850. It is to be noted that the salary for a clinical trial coordinator may vary depending on several factors like:
- Level of education
- Amount of experience
- Company size
- Location (7)
The average pay for a clinical trial coordinator is 180,668 INR per year. (8)