Senior Clinical Research Associate
Location: Zaventem, Belgium
Take your therapeutic expertise to the next level and help drive the evolution of clinical development for a variety of sponsors.
As a Clinical Research Associate within our full-service model, you’ll have the opportunity to embrace your passion for a specific therapeutic
area and work with cutting-edge technology developed specifically for CRAs by CRAs. With access to world-class training and professional
development, we’ll give you the tools you need to create the career you want.
- Full Time
- Level: Entry-level, Mid-level, Senior-level
- Travel: Yes
What makes CRAs aligned to our full-service model successful? Check out the top traits we're looking for and see if you have the right mix.
As you grow your CRA career at IQVIA, you’ll play an important role in helping our customers drive healthcare forward and impact the lives of patients around the world.
“IQVIA empowers you to drive your own path within the organization. As no person’s route is the same and the clinical research landscape is forever changing, you are encouraged to continually seek career growth opportunities and to align your interests with your career goals.”Lauren, Senior Clinical Research Associate 2
“I really enjoy the diversity of teams and clients the CRA role provides, in addition to the ability to speak with so many different key opinion leaders across the country. Progressing through to a Senior CRA, and now acting as Lead CRA for one of our largest gastroenterology studies, I'm excited at the continued opportunities for success and growth in clinical leadership.”Joseph, Senior Clinical Research Associate 2
“I work with the most incredible brave minds. We share energy and passion to bring new medicines to the market.”Carolina, Senior Director, R&D Solutions
Resources that promote your career growth
Leaders that support flexible work schedules
Programs to help you build your therapeutic knowledge
Dynamic work environments that expose you to new experiences
Clear pathways to success
Protocols aligned to your expertise
Senior Clinical Research Associate
Responsible for the monitoring activities at assigned sites to ensure that clinical research studies adhere to standard protocols, ICH-GCP and SOPs.
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
-Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
-Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
-Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
-Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
-Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
-Manage the progress of assigned studies by tracking recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
-Ensure copies/originals (as required) of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Collaborate and liaise with study team members for project execution support as appropriate.
-If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
-If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
-If applicable, may act as mentor for junior CRAs and perform accompanied site visits with junior CRAs
-If applicable, may act as lead CRA for particular projects and/or clients
-Master or Bachelor's degree: Degree in scientific discipline or health care preferred.
-Requires at least 2 years of year of on-site monitoring experience.
-Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
-Good therapeutic and protocol knowledge as provided in company training.
-Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
-Strong written and verbal communication skills including good command of English, Dutch and French language.
-Organizational and problem-solving skills.
-Effective time and financial management skills.
-Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Typically within travel within country or region (avg 8 days on-site per month); Might require travel to other countries.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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