At a Glance
- Tasks: Conduct site management and monitoring to ensure compliance and data integrity.
- Company: Join Syneos Health®, a leader in biopharmaceutical solutions.
- Benefits: Gain valuable experience, competitive pay, and opportunities for growth.
- Other info: Exciting opportunity to join a talent pipeline for future roles.
- Why this job: Make a real difference in clinical research and patient safety.
- Qualifications: Bachelor’s degree or RN, with knowledge of clinical practices.
The predicted salary is between 35000 - 45000 € per year.
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.
Job Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site‑specific actions; immediately communicates/escalates serious issues to the project team.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
- Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Conducts Source Document Review of appropriate site source documents and medical records and verifies required clinical data entered in the case report form (CRF) is accurate and complete.
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
- Documents activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
- Manages site‑level activities / communication to ensure project objectives, deliverables and timelines are met.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow‑up actions.
Qualifications
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Excellent communication, presentation and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.
We are always excited to connect with great talent. This posting is intended for a possible upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
Clinical Research Associate employer: Syneos Health
At Syneos Health®, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the biopharmaceutical sector. Our commitment to employee growth is evident through continuous training opportunities and a supportive environment that encourages professional development. Located in a vibrant area, we provide our Clinical Research Associates with the unique advantage of engaging in meaningful work that directly impacts patient lives while enjoying a balanced work-life experience.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Associate
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical research field on LinkedIn or at industry events. We can’t stress enough how personal connections can lead to job opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. We recommend practising common interview questions and having your own questions ready. Show them you’re genuinely interested in their work and how you can contribute!
✨Tip Number 3
Follow up after interviews! A simple thank-you email can go a long way. It shows your enthusiasm for the role and keeps you fresh in their minds. We love seeing candidates who take that extra step!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we’re always on the lookout for passionate individuals ready to make an impact in clinical research.
We think you need these skills to ace Clinical Research Associate
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Clinical Research Associate role. Highlight any relevant qualifications, especially those related to Good Clinical Practice and site management activities.
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 background makes you a great fit for our team at Syneos Health. Keep it engaging and personal.
Showcase Your Communication Skills:Since this role requires excellent communication, make sure your application showcases your ability to convey information clearly. Whether it's in your CV or cover letter, demonstrate how you've effectively communicated in past roles.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for future opportunities as they arise. Plus, it’s super easy!
How to prepare for a job interview at Syneos Health
✨Know Your GCP and ICH Guidelines
Make sure you brush up on Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines. Being able to discuss these in detail will show that you understand the regulatory landscape and can ensure compliance at every stage of clinical research.
✨Demonstrate Your Site Management Skills
Prepare examples from your past experiences where you've successfully managed site activities or resolved issues. Highlight your ability to communicate effectively with site staff and how you’ve ensured project objectives were met, as this is crucial for a Clinical Research Associate.
✨Showcase Your Problem-Solving Abilities
Think of specific instances where you’ve had to use your judgment to evaluate site performance or address safety concerns. Be ready to discuss how you approached these challenges and what the outcomes were, as this will demonstrate your critical thinking skills.
✨Be Ready for Technical Questions
Since the role involves using various technologies, be prepared to discuss your computer skills and any relevant software you’ve used in previous roles. Familiarise yourself with common tools in clinical research to show that you can hit the ground running.
