At a Glance
- Tasks: Monitor clinical trials, ensuring compliance and supporting project teams in site selection and training.
- Company: Join a global leader in clinical research with a supportive and award-winning culture.
- Benefits: Enjoy career growth, tuition reimbursement, health benefits, and hybrid work options.
- Other info: Dynamic team environment with opportunities for professional development and mentorship.
- Why this job: Make a real impact on patients' lives by advancing critical medical treatments.
- Qualifications: 1 year of research experience and a degree in health-related fields required.
The predicted salary is between 30000 - 40000 € per year.
Responsibilities
- Perform in‑house monitoring activity related to clinical trials while adhering to all applicable regulatory and SOPs.
- Perform on‑site clinical trial monitoring, co‑monitoring, and close‑out activities, with oversight from project CRAs when required.
- May conduct independent on‑site monitoring as sponsor requirements allow.
- Assist project teams with study start‑up activities, including site selection and phone Pre‑Study Visits to identify and evaluate potential investigative sites.
- Collect, review, file, and track regulatory documents for investigative sites, when required.
- Participate in or conduct study‑specific training for CTI personnel or investigative sites.
- Attend Investigator or sponsor meetings.
- Assist in development of monitoring tools for study, including remote monitoring checklist for eCRF studies.
- Conduct routine remote monitoring of eCRF studies, issuing queries in the database.
- Compile monitoring visit packets and provide to project CRAs prior to on‑site monitoring visits.
- Assist in maintaining project‑related tracking for CRA visit reports and letters, protocol deviations, serious adverse events (SAEs), and IND Safety reports.
- Contact sites to ensure proper completion of monitoring/data management queries within timelines.
- Serve as support/contact for CRA Team questions.
- Assist with project‑specific administrative activities as a member of the project team.
- Increase knowledge of drug development process, therapeutic areas, ICH/GCP, and any applicable local regulatory requirements.
Qualifications
- 1 year of research industry experience or equivalent experience.
- Bachelor’s degree in allied health fields such as nursing, pharmacy, or health/natural science.
- RN with Associate’s Degree.
Preferred Education and Experience
- Previous experience conducting clinical pharmaceutical research studies at research site, pharmaceutical company, or CRO.
- Experience or education providing sound basic knowledge of medical and pharmaceutical terminology.
- Master’s Degree in allied health fields such as nursing, pharmacy, or health/natural science.
- Excellent verbal and written communication skills.
- Excellent organizational, record retention, and time management skills.
- Excellent decision‑making, customer service, and interpersonal skills.
- Ability to process visit reports and expense reports effectively.
- Ability to obtain credit cards for purpose of paying expenses while traveling.
- Ability to work independently and as part of a project team.
- Proficient in use of laptop computer and software systems.
- Ability to understand basic and complex medical details.
- Understanding of basic data processing functions is preferred.
- Knowledge of ICH/GCP and all applicable local regulatory requirements is preferred.
Benefits
- Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow.
- Join an Award‑Winning and Valued Team – We have an award‑winning unparalleled culture that can be felt by our employees across 60 countries.
- Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically‑ill patients.
Clinical Mon Assoc I employer: Consulting, Inc.
As a Clinical Mon Associate I, you will thrive in an award-winning culture that prioritises employee well-being and career advancement. With access to structured mentoring, ongoing education, and generous health benefits, our company fosters a supportive environment where you can make a meaningful impact on patients' lives while enjoying a healthy work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Mon Assoc I
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the lookout for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Get involved in relevant online communities or forums. Engaging with others in the industry can help you stay updated on job openings and trends, plus it’s a great way to showcase your knowledge and passion for clinical trials.
✨Tip Number 3
Don’t just apply – follow up! After submitting your application through our website, drop a quick email to the hiring manager expressing your enthusiasm for the role. It shows initiative and keeps you on their radar.
✨Tip Number 4
Prepare for interviews by brushing up on your knowledge of ICH/GCP guidelines and the drug development process. Being well-versed in these areas will not only impress your interviewers but also boost your confidence!
We think you need these skills to ace Clinical Mon Assoc I
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Clinical Mon Assoc I role. Highlight any relevant experience in clinical trials, monitoring, or regulatory compliance. We want to see how your background fits with what we do!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical research and how your skills align with our mission at StudySmarter. Keep it engaging and personal.
Showcase Your Skills:Don’t forget to highlight your excellent communication, organisational, and time management skills in your application. These are key for the role, and we want to know how you’ve used them in past experiences.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the info you need about the role and our company culture there!
How to prepare for a job interview at Consulting, Inc.
✨Know Your Stuff
Make sure you brush up on your knowledge of clinical trials, ICH/GCP guidelines, and the drug development process. Being able to discuss these topics confidently will show that you're serious about the role and understand the industry.
✨Showcase Your Experience
Prepare specific examples from your past experiences that highlight your skills in monitoring, data management, and communication. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make them impactful.
✨Ask Smart Questions
Come prepared with thoughtful questions about the company’s projects, team dynamics, and growth opportunities. This not only shows your interest but also helps you gauge if the company is the right fit for you.
✨Demonstrate Team Spirit
Since this role involves working closely with project teams and CRAs, emphasise your ability to collaborate effectively. Share examples of how you've successfully worked in a team setting and supported others in achieving common goals.