The Study Start-Up Specialist Role
a great role for Newcomers in Clinical Research
Are you interested in a career in clinical research? Do you have a passion for ensuring that clinical trials are conducted safely, efficiently, and in compliance with regulatory requirements? If so, you may want to consider a role as a Study Start-Up Specialist.
In this blog post, we’ll explore the key responsibilities, skills, and qualifications needed to excel in this exciting and rewarding role.
Why this is an interesting role?
Becoming a Study Start-Up Specialist can be a rewarding career choice because it involves overseeing and managing the crucial early stages of clinical trials, ensuring they are initiated and executed properly. This can involve working with a variety of stakeholders, including investigators, regulatory agencies, and study sponsors, and requires a strong attention to detail, communication skills, and knowledge of relevant regulations and guidelines. Additionally, the field of clinical research is growing, and there is a high demand for qualified professionals in this area.
The salary of a study start-up specialist can vary depending on factors such as their level of experience, location, and the type of organization they work for. According to Glassdoor, the average base salary for a Study Start-Up Specialist in the United States is around $75,000 per year, with a range between $52,000 to $105,000. However, salaries can be higher for those with more experience or who work in certain industries or regions. It’s important to note that these figures are just estimates and may not reflect the exact salary of every individual in this role.
The Study Start-Up Specialist role is a crucial part of the clinical research process, ensuring that trials are initiated properly and in compliance with regulatory requirements. If you have a passion for clinical research and the skills and qualifications outlined in this post, this could be the perfect role for you.
Typical tasks and responsibilities
As a Study Start-Up Specialist, your primary responsibility is to ensure that clinical trials are initiated properly and in a timely manner. This includes supporting tasks such as:
- Planning and managing the start-up activities of clinical trials
- Ensuring compliance with regulatory requirements and guidelines
- Identifying and recruiting study sites and investigators
- Preparing and submitting regulatory documents, such as informed consent forms and ethics committee applications
- Coordinating with study monitors to ensure proper training and site initiation
- Managing study budgets and timelines
- Ensuring proper documentation and record-keeping throughout the study start-up process.
Multiple Educational Backgrounds work
A bachelor’s degree in a related field, such as life sciences, health sciences, or a related discipline, is typically required. Some organizations may prefer or require a master’s degree in a relevant field. Most organizations prefer candidates who have some working experience. A good understanding of the regulatory requirements and guidelines governing clinical research is essential. This includes knowledge of Good Clinical Practice (GCP) guidelines and other relevant regulations. Strong organizational skills, attention to detail, and communication skills are crucial for success in this role. Candidates should also be comfortable working with stakeholders from a variety of backgrounds, such as investigators, regulatory agencies, and study sponsors.
Overall, a combination of education, experience, knowledge, skills, and certifications can help you become a competitive candidate for a Study Start-Up Specialist role.
If you are not sure if this is the right training for you, we are happy to help you make the right decision. Email us at firstname.lastname@example.org and we will contact you.
Become Trained and Certified
If you’re interested in becoming a Study Start-Up Specialist, consider obtaining your certification through VIARES. We offers a comprehensive training and certification program for clinical research professionals, including the Study Start-Up Specialist certification.
With VIARES, you’ll receive high-quality training from experienced professionals in the field, gain practical skills and knowledge, and be prepared to take your career in clinical research to the next level. Don’t wait – start your journey towards becoming a certified Study Start-Up Specialist with VIARES today.
The Study Start-Up Specialist role is an excellent entry point for newcomers to the healthcare and research industries. With opportunities for growth and career advancement, this role can be a rewarding and fulfilling career choice. Become certified as a Study Start-Up Specialist by VIARES and take the first step towards a career in clinical research.
Hear from our Graduates
VIARES already supported 5500+ talents from 100+ countries on all continents. Here is a Snapshot of Graduate Experience and how they benefited from our Clinical Research Training Courses and Job Support.
IzabelaClinical Trial Administrator, IQVIA
I wanted to progress in my career, as I already was working in the field of clinical research. For me the course was a great experience, I learned a lot. I was able to broaden my knowledge about clinical trials and now
I feel prepared for the interviews and career steps to come! The teachers were extremely good trained and it was a pleasure to learn from them.
VassilClinical Coordinator, KCR CRO
Proud to announce that I have passed the Final Exam on the VIARES Clinical Research Talent Program. I strongly recommend it to all people interested in the field of clinical trials. Of course many thanks to Dietmar Eglhofer for creating this program
and all the great tutors: Eric Klaver, Gavin Chait and Gabriele Disselhoff.
ShilpaMSL Team Manager, Abbott
The VIARES Clinical Research Talent Program provided me a great opportunity to refresh and rebuild my clinical research skills and competencies. The program was well structured and covered the key aspects related to clinical research, drug
development, ICH guidelines, and clinical research regulations. The self-learning modules, followed by live webinars led by subject matter experts, provided the participants a platform to understand the key concepts and engage in great dialogue and discussions. I thank VIARES for giving me this opportunity and highly recommend this program to professionals looking to start a career in clinical research.
IwonaClinical Trial Administrator, DOCS (ICON) with Janssen
VIARES Academy supported me at every step in my course and answered my questions instantly. Moreover the platform is very organized and I could find my way around very fast.
The course content provided by the courses at VIARES have helped me to improve my knowledge at my current job as a clinical trials assistant.