Clinical Study Assistant Job Description, Key Duties and Responsibilities

This post provides detailed information on the clinical study assistant job description, including the key duties, tasks, and responsibilities they commonly perform.

It also explores the knowledge, skills, and certifications required for individuals interested in pursuing a career as a clinical study assistant, CSA.

Whether you aspire to be a CSA yourself or simply wish to gain insight into their contributions to the field of medicine, keep reading to discover more about these heroes of healthcare.

Clinical study assistants play a role in the advancement of healthcare and medical science by contributing to the development of medical treatments and procedures.

The primary responsibility of a clinical study assistant (CSA) is to provide support in trials aimed at testing new drugs, devices, and treatment methods.

They are team members who contribute to making groundbreaking discoveries possible.

What Does a Clinical Study Assistant Do?

The role of the clinical study assistant is diverse and vital in supporting aspects of clinical trials.

The clinical study assistant job description involves managing and coordinating day to day operations throughout the trial, ranging from initiating site activities, to collecting and documenting data.

Clinical study assistants typically report to a clinical study coordinator, clinical project manager, or directly to the principal investigator.

They work in settings such as pharmaceutical companies, study organizations, hospitals, academic institutions and government agencies.

These organizations employ study assistants to conduct their trials.

To become a study assistant one usually needs a Bachelor’s degree in a science or health related field.

Many individuals in this role have backgrounds in nursing, pharmacy, or medical technology. Having certification like ACRPs CCSA credential is often preferred.

In addition to their core responsibilities, clinical study assistants may also contribute to study design efforts, write progress reports, prepare submissions, and coordinate with trial sites.

The contribution of study assistants is crucial for the advancement of clinical study, since they ensure that ethical and scientific standards are upheld worldwide.

Employers are seeking clinical study assistants (CSAs) who possess an eye, for detail, exceptional organizational and communication skills, proficiency in computer usage, thinking abilities, and the capacity to work independently.

In the United States, the Food and Drug Administration (FDA) holds authority over drugs and medical devices.

CSAs play a role in ensuring study adheres to these regulations.

Clinical Study Assistant Job Description Example/Sample/Template

The clinical study assistant job description consists of the following duties, tasks, and responsibilities:

Review study protocols and comprehend all procedures involved
Assist in the submission of ethics applications and obtain approval from oversight committees
Share study information and recruitment materials to generate interest among participants
Identify individuals who meet the study’s criteria
Schedule study visits and coordinate logistics related to travel or accommodations
Obtain consent from participants before their enrollment in the study
Conduct clinical interventions and necessary tests as outlined by the study protocol
Maintain monitoring of health while being vigilant for any potential adverse events
Collect samples, such as blood or tissue specimens, appropriately prepare them for shipment
Record accurate documentation of all study procedures performed, as well as maintain comprehensive participant health data records
Collaborate with sponsors and investigators to prepare final study reports
Address data related inquiries
Ensure resolution of any issues
Verify the completeness of study documentation and maintain it in the Investigator Site File
Manage tasks related to project closure, such as returning study supplies and archiving records
Keep track of inventory records for study supplies, including usage and disposition
Ensure that facilities and equipment used in the study meet the required standards
Adhere to data privacy policies while maintaining confidentiality at all times
Comply with Good Clinical Practice (GCP) guidelines and uphold Study principles
Build relationship with both the study sponsor and the Contract Study Organization (CRO) throughout the trial period.

Clinical Study Assistant Job Description for Resume

If you have worked before as a clinical study assistant or are presently working in that role and are making a new resume or CV, then you can create a compelling Professional Experience section for the resume by applying the sample clinical study assistant job description example above.

You can highlight the duties and responsibilities you have carried out or are presently performing as a clinical study assistant in your resume’s Professional Experience by utilizing the ones provided in the clinical study assistant job description sample above.

This will show to the recruiter/employer that you have been successful performing the role of a clinical study assistant, which can greatly enhance the effectiveness of your resume or CV, especially if the new job that you are seeking requires someone with some clinical study assistant work experience.

Clinical Study Assistant Skills, Knowledge, and Abilities for Successful Clinical Study Assistant Career

Here are important competencies, knowledge, and abilities usually required for hiring for the clinical study assistant position:

Knowledge:

Understanding of clinical study principles and practices
Proficiency in Study ethics and adherence to good clinical practice guidelines
Familiarity with various study methodologies
Background in life sciences or healthcare
Detail-oriented to track protocols and SOPs

Skills:

Strong written and verbal communication abilities for effective and clear communication with study participants, staff members and other stakeholders involved in the study project is essential
Ability to clearly explain complex information
Address questions and concerns from various audiences
Computer proficiency to enter data and navigate systems
Being adaptable to changing priorities and deadlines demonstrates flexibility, which is an aspect of the clinical study assistant role.

Abilities:

Extremely organized to juggle multiple tasks
Flexible when studies do not go fully as planned
Focused to produce quality work under tight deadlines

Clinical study assistant bring several competencies to the table. They bring solid knowledge, team spirit, and high level of focus and organizational prowess necessary for performing the role.

Clinical Study Assistant Salary

Regarding salary, clinical study assistants earn around $46,840 as documented by the Bureau of Labor Statistics, 2022.

It is worth noting that the best paying states for study assistants in 2022 were Maryland, with salary of $73,270, Hawaii, $69,520; Virginia, $68,690; the District of Columbia, $67,500; and Connecticut, $66,810.