Job Summary:
A Clinical Trial Assistant is responsible for providing administrative support to clinical trials in the healthcare industry. They assist medical professionals involved in clinical research by organizing, managing and maintaining clinical trial documentation.
Responsibilities:
- Provide administrative support to clinical trials, including preparation of documents and reports, maintaining trial master files and document storage, and coordinating logistics for meetings, conferences and training sessions.
- Assist with the development of clinical trial protocols, informed consent forms and study reports in accordance with Good Clinical Practice (GCP) and applicable regulations.
- Act as the primary point of contact between study site personnel, sponsors and vendors to ensure timely communication and resolution of issues.
- Track study progress and provide regular updates to study team members and other stakeholders.
- Assist with the preparation and submission of regulatory documents to obtain and maintain trial approval.
- Maintain accurate and up-to-date clinical trial records and ensure compliance with all relevant regulations and guidelines, including FDA, ICH and GCP.
- Participate in study team meetings and provide input on trial design and execution.
Requirements:
- Bachelor's degree in a scientific or healthcare related field, or equivalent experience.
- At least 1-2 years of experience supporting clinical trials in a healthcare or pharmaceutical setting.
- Knowledge of GCP, FDA regulations, and other relevant guidelines and regulations governing clinical trials.
- Excellent organizational, communication and interpersonal skills.
- Ability to work effectively in a team-oriented environment with multiple stakeholders.
- Proficient in Microsoft Office Suite and other database software.
- Experience with electronic data capture systems is preferred.
Introduction
A clinical trial assistant (CTA) plays a vital role in supporting clinical research teams in conducting trials. Therefore, hiring the right CTA is imperative to ensure the efficient functioning of clinical trials. This article provides you with a step-by-step guide on how to create a CTA job posting that will attract the right candidates.
Job Title and Job Summary
Your job posting should have a clear title that accurately summarizes the job role. Your CTA job title should be "Clinical Trial Assistant." In the job summary, you should describe the main responsibilities of the job. For instance:
- Assisting in study start-up activities, site monitoring, and study close-out.
- Preparing regulatory documents and ensuring compliance with regulatory guidelines.
- Performing administrative tasks such as filing, data entry, and coordinating meetings.
- Assisting in participant recruitment and screening activities.
- Managing study supplies and ensuring timely deliveries to study sites.
Qualifications and Experience
In this section, you should outline the required qualifications and experience that an ideal candidate should have. For instance:
- Bachelor’s degree in a relevant field.
- Experience working in a clinical research environment.
- Knowledge of regulatory guidelines such as ICH-GCP and FDA regulations.
- Excellent organizational and communication skills.
- Strong attention to detail and ability to work under pressure.
Working Conditions
Here, you should provide information about the working conditions that the candidate will be working in. For instance:
- The job is primarily office-based, but some travel may be required.
- May be required to work overtime to meet deadlines.
- The candidate should be willing to work as part of a team and also independently.
Benefits and Salary
This section should give a brief overview of the benefits that the candidate will receive and the salary range for the job. For instance:
- The successful candidate will be offered a competitive salary.
- Other benefits include health insurance, pension, and generous vacation time.
Conclusion
In conclusion, creating a well-written job posting for a CTA position will attract the right candidates and help you find the perfect fit for your clinical research team. Remember to be clear and concise in your job posting and highlight the key requirements of the job.
Hiring a Clinical Trial Assistant: Frequently Asked Questions
What is a Clinical Trial Assistant?
A Clinical Trial Assistant is responsible for providing administrative support to clinical research teams. They perform various tasks such as maintaining study files, tracking study progress, and preparing trial documents. A Clinical Trial Assistant is expected to be detail-oriented, organized, and possess excellent communication and problem-solving skills.
What qualifications should a Clinical Trial Assistant have?
A Clinical Trial Assistant should hold a Bachelor's degree, preferably in life sciences, nursing, or a related field. Additionally, experience in clinical research, project management, or administrative support is often required. Along with education and experience, important qualities for a Clinical Trial Assistant include strong attention to detail, excellent communication skills, and the ability to manage time effectively.
What are the responsibilities of a Clinical Trial Assistant?
What are some key skills required for a Clinical Trial Assistant?
A Clinical Trial Assistant should possess excellent organizational and problem-solving skills. They must be able to work independently and manage multiple tasks within tight deadlines. Strong proficiency in Microsoft Office is often required. Furthermore, effective communication skills are a must-have, as a Clinical Trial Assistant must be able to work and communicate effectively with all team members.
What is the typical salary for a Clinical Trial Assistant?
Salaries for Clinical Trial Assistants can vary depending on the level of experience, location, and company size. According to Glassdoor, the average salary for a Clinical Trial Assistant in the United States is $52,274 per year.
