Clinical Research Associate – (Zagreb,
mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All
in-between, it’s you! We know that meaningful results not only require the right approach,
but also the right people. We invite you to re-imagine health promoting protocols with us,
working alongside our talented, bright and energetic teams.
clinical department defines, develops and delivers clinical programmes. We ensure the
highest-quality review of data and effective interaction with study sites, including on-site
monitoring throughout a study, ensuring that patients receive needed care, as well as identifying
and treating clinical trial participants.
Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.
As a PPD CRA, you will perform and coordinate all aspects of the clinical monitoring and site management process. The CRAs conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. They manage procedures and guidelines from different sponsors and/or monitoring environments. Part of the responsibilities is to act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. They also ensure audit readiness and develop collaborative relationships with investigational sites. In addition, some responsibilities also include:
status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management
System, CTMS). Performs QC check of reports generated from CTMS system where
investigator meetings as necessary. Identifies potential investigators in collaboration with the
client company to ensure the acceptability of qualified investigative sites. Initiates clinical
trial sites according to the relevant procedures to ensure compliance with the protocol and
regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close
out and retrieval of trial materials.
Ensures that required
essential documents are complete and in place, according to ICH-GCP and applicable regulations.
Conducts on-site file reviews as per project specifications.
· Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
If this sounds like you, you need to have:
Education and Experience:
· Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
At least 2 years
experience as a CRA
Knowledge, Skills and Abilities:
· Effective clinical monitoring skills
· Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
· Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
· Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
· Ability to manages Risk Based Monitoring concepts and processes
· Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
· Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
· Good English language and grammar skills
What we offer
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
You will receive an initial and ongoing
training with the option to develop and build upon your skills. You will learn more about the
industry and expand your knowledge on a global level.
have a strong will to win - We earn our customer’s trust - We are game changers - We do the right
thing - We are one PPD
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.