What Does a Clinical Trial Associate Do?

Clinical trial associates (CTAs) are the liaisons between pharmaceutical companies and clinical research sites. They work with doctors, nurses, and other medical professionals to ensure that clinical trials are conducted properly and on schedule.

Clinical trial associates must be detail-oriented individuals who can juggle multiple projects at once. They often have a lot of contact with both doctors and patients, so they need to be able to communicate effectively in both cases.

Clinical Trial Associate Job Duties

Clinical trial associates have a wide range of responsibilities, which can include:

• Coordinating patient intake, including collecting medical and personal information and entering it into a database
• Reviewing and approving study proposals prior to submission to ethics boards or Institutional Review Boards (IRBs) for approval
• Communicating with patients about their participation in clinical trials by providing them with information about the study protocol, risks, and expected results
• Maintaining accurate records of all activities related to the study, including patient enrollment and discharge, adverse events, and other details about subjects’ participation in the research
• Preparing reports summarizing patient demographics, medical conditions, and test results.
• Coordinating with other departments within a company, such as research and development, marketing, and accounting, to ensure that all aspects of a study are carried out successfully
• Coordinating with regulatory agencies such as the Food and Drug Administration (FDA) or the Institutional Review Board (IRB) to ensure that studies are conducted ethically and within legal guidelines
• Monitoring patient safety throughout the duration of the study by regularly reviewing medical records and consulting with physicians, nurses, and other staff members involved in the study
• Collecting data on patient reactions or responses to drugs or other treatments

Clinical Trial Associate Salary & Outlook

Clinical trial associates’ salaries vary depending on their level of education and experience, the company size and geographic location.

• Median Annual Salary: $70,500 ($33.89/hour)
• Top 10% Annual Salary: $143,000 ($68.75/hour)

The employment of clinical trial associates is expected to grow faster than average over the next decade.

As pharmaceutical companies seek to develop new drugs and medical devices, demand for clinical trial associates will increase. Clinical trials are a crucial part of the drug development process. Clinical trial associates will be needed to ensure that these trials are conducted properly and that the data collected are accurate.

Related: Clinical Trial Associate Interview Questions and Answers

Clinical Trial Associate Job Requirements

A clinical trial associate typically needs to have the following qualifications:

Education: Most employers require clinical trial associates to have a bachelor’s degree in a science-related field, such as biology, chemistry or pharmacology. Some employers may accept a related associate degree, such as a bachelor’s degree in health science or pre-medicine.

Training & Experience: Clinical trial associates typically receive on-the-job training from their new employer. This training may include shadowing a current clinical trial associate or learning the specific software and processes the company uses.

Certifications & Licenses: Clinical trial associates do not need certifications to get hired, but they can earn certifications to improve their chances of getting a job and increasing their earning potential.

Clinical Trial Associate Skills

Clinical trial associates need the following skills in order to be successful:

Communication: Clinical trial associates must be able to communicate effectively with their colleagues and the patients they work with. They must be able to explain the purpose of the clinical trial, answer any questions patients may have and explain any procedures or tests that patients may need to undergo. They also must be able to communicate with the research team to ensure that the clinical trial is running smoothly.

Organization: Clinical trial associates must be able to maintain a high level of organization in their work. This includes keeping track of paperwork, maintaining a calendar of important dates and events and keeping track of research materials and data. Clinical trial associates must also be able to organize files and records for the research team.

Attention to detail: Attention to detail is a necessary skill for clinical trial associates to have, as they often handle sensitive information and data. This skill can help them ensure that they enter the correct information into the trial database and that they send the correct information to the trial sponsor. Attention to detail can also help them ensure that they follow the trial protocol correctly and that they complete all tasks in a timely manner.

Scientific knowledge: Clinical trial associates should have a basic understanding of medical research and the scientific process. They should be able to read and interpret medical research data and understand the purpose of clinical trials. They should also be able to explain the trial process to patients and other members of the research team.

Problem-solving: Clinical trial associates may be responsible for identifying and resolving issues that arise during a clinical trial. This may include finding solutions to issues with patient recruitment, ensuring that patients are following the trial protocol correctly or finding ways to overcome logistical challenges. Being able to identify and solve problems is an important skill for clinical trial associates to have.

Clinical Trial Associate Work Environment

Clinical trial associates work in a variety of settings, including hospitals, clinics, pharmaceutical companies, and research institutions. They typically work regular business hours, although they may be required to work evenings or weekends to attend meetings or to complete paperwork. Clinical trial associates may experience a high level of stress due to the demanding nature of the job and the need to meet deadlines. They must be able to handle multiple tasks simultaneously and be able to work well under pressure.

Clinical Trial Associate Trends

Here are three trends influencing how clinical trial associates work. Clinical trial associates will need to stay up-to-date on these developments to keep their skills relevant and maintain a competitive advantage in the workplace.

The Need for More Clinical Trial Operators

The need for more clinical trial operators is a trend that is quickly emerging in the pharmaceutical industry. This is due to the increasing demand for new and innovative drugs, which requires a larger pool of clinical trial participants.

As a clinical trial associate, you can capitalize on this trend by becoming an expert in recruiting and screening potential participants. You will also need to be able to manage the logistics of clinical trials, such as setting up appointments and tracking participant data.

More Focus on Patient-Centered Care

The healthcare industry is rapidly changing, with one of the most significant changes being the increased focus on patient-centered care. This shift is driven by the realization that patients are now more informed about their options and want to be involved in decisions about their treatment.

Clinical trial associates can capitalize on this trend by becoming experts in patient-centered care. This includes understanding how to communicate with patients and their families, as well as developing relationships with them. In addition, clinical trial associates should be familiar with the latest trends in patient-centered care so that they can help their company stay ahead of the curve.

Greater Use of Technology in Clinical Trials

The use of technology in clinical trials is becoming increasingly common as researchers look for ways to streamline the process and collect data more efficiently.

This trend is having a major impact on the role of the clinical trial associate, who is now responsible for managing and maintaining all of the technology used in the trial. As technology becomes more important in clinical trials, clinical trial associates will need to be comfortable working with it and know how to use it effectively.

How to Become a Clinical Trial Associate

A clinical trial associate (CTA) career can be a great way to get started in the pharmaceutical industry. As a CTA, you’ll have the opportunity to work with a variety of professionals and learn about different aspects of drug development. You’ll also gain experience working within a team environment and learning how to effectively communicate with patients.

To become a CTA, you’ll need to have a science-related degree and be able to pass the Pharmacy Technician Certification Exam. Additionally, it’s important to have strong communication skills and be able to work well under pressure.

Advancement Prospects

Clinical trial associates typically need a bachelor’s degree in a scientific discipline, such as biology, chemistry, or nursing, although some jobs may only require an associate’s degree or a high school diploma.

Clinical trial associates may advance to positions with more responsibility, such as clinical research coordinators or managers. Some clinical trial associates may also become principal investigators, who are responsible for the overall conduct of a clinical trial. With experience, clinical trial associates may move into other research-related positions in the pharmaceutical industry or in academia.

Clinical Trial Associate Job Description Example

The [CompanyX] team is looking for a highly-organized and detail-oriented clinical trial associate (CTA) to support our clinical research department. The CTA will be responsible for assisting with the planning and execution of clinical trials, as well as ensuring compliance with all applicable regulations. He or she will work closely with the clinical research team, as well as other departments within the company, to ensure that clinical trials are conducted according to protocol and within budget. The ideal candidate will have experience working in a clinical research setting, as well as a strong understanding of the clinical trial process.

Duties & Responsibilities

• Serve as the primary contact for assigned clinical sites, providing support throughout all phases of the clinical trial
• Develop and maintain strong working relationships with clinical site staff, ensuring timely and accurate communication
• Review clinical site documentation for completeness and accuracy, according to protocol and ICH/GCP guidelines
• Assist with the development and implementation of clinical trial plans, timelines, and budgets
• Track clinical site progress and performance against milestones, identifying and addressing any delays or deviations
• Manage clinical trial supplies and inventory, ensuring that sites have what they need when they need it
• Coordinate and attend clinical team meetings, taking minutes and following up on action items
• Prepare and distribute study-related correspondence to clinical sites, as needed
• Serve as a resource for clinical site staff on protocol-related questions
• Monitor adverse events and serious adverse events, per protocol and ICH/GCP guidelines
• Review and track clinical site invoices for accuracy and compliance
• Assist with the development and maintenance of clinical trial databases

Required Skills and Qualifications

• Bachelor’s degree in a scientific discipline
• 1-2 years experience working in a clinical research setting
• Working knowledge of GCP and ICH guidelines
• Excellent communication, writing, and organizational skills
• Ability to work independently and as part of a team
• Proficient in Microsoft Office applications

Preferred Skills and Qualifications

• Master’s degree or higher in a scientific discipline
• Certification in clinical research (CCRC, ACRP, SOCRA, etc.)
• Experience with clinical trial management software
• Familiarity with medical terminology
• Bilingualism