Clinical Research Associate - Romania
Location: Bucharest, Romania
Req. #: R1191864
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
Clinical Research Associate - Romania
Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. If applicable, Clinical Research Associates may be accountable for development of project subject recruitment plan on a per site basis. Support work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
- Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- 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 regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- 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.
- Build awareness of features and opportunities of study to site.
- Collaborate and liaise with study team members for project execution support as appropriate.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Basic 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 and use of a lap top computer
- Good written and verbal communication skills including good command of English language
- Good organizational and problem-solving skills
- Effective time management skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in a health care or other scientific discipline or educational equivalent and successful completion of a CRA Trainee Program
- At least 3+ months of on-site monitoring experience in a CRO or pharmaceutical environment
- Fluent in English
- Availability to travel
At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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