Clinical Research Associate (CRA)
Location: Sofia, Bulgaria
R1304511
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
Success profile
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.
- ANALYTICAL
- ORGANIZED
- COMMUNICATOR
- PROBLEM-SOLVER
- FACILITATOR
- VERSATILE
Explore this
career path
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.
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CRA 1
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CRA 2
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Senior
CRA 1 -
Senior
CRA 2 -
Senior
CRA 3
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What you
can expect
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Professional Development
Resources that promote your career growth
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Work-Life Balance
Leaders that support flexible work schedules
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Best-in-class Training
Programs to help you build your therapeutic knowledge
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Variety
Dynamic work environments that expose you to new experiences
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Growth Potential
Clear pathways to success
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Therapeutically Aligned
Protocols aligned to your expertise
Clinical Research Associate (CRA)
Job description
We are looking to recruit committed individuals to work in a busy clinical research department providing essential monitoring support.
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, 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.
RESPONSIBILITIES
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 and Bulgarian.
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 6+ months of on-site monitoring experience in a CRO or pharmaceutical environment
Fluent in English and Bulgarian
Availability to travel 80%
The role provides the opportunity to develop monitoring skills with advanced responsibilities, critical and central to the conduct of the clinical project. We are offering a hybrid flexible working place model (home-office) based.
Unleash your Potential!
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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