PPD İstanbul Turkey
2 months ago
PPD, now Thermo Fisher’s clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.
PPD clinical research service’s mission is to . It starts as an idea to 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 .
Our 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 :
Providing trial 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 required.
Participation in 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).
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
• Advanced English language and grammar skills
What We Offer
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize 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 clinical research services you will benefit from an , 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 , where PPD clinical research services 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 organization 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.
Our 4i Values :
Integrity Innovation Intensity Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application we’d love to hear from you!
If you are interested in learning more, please submit your resume and we’ll set up a time to connect!
As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.
(Senior) Clinical Research Associate- Türkiye İstanbul jobs
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