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PPD

CRA (Level II) - Russia (all locations)

Clinical Research Associate - (All Russialocations)



PPD's mission isto improve health. It starts as an idea to find a cure. It becomes a lifesaved. All in-between, it's you! We know that meaningful results not onlyrequire the right approach, but also the right people. We invite you tore-imagine health promoting protocols with us, working alongside our talented,bright and energetic teams.

Theteam



Our clinicaldepartment defines, develops and delivers clinical programmes. We ensure thehighest-quality review of data and effective interaction with study sites,including on-site monitoring throughout a study, ensuring that patients receiveneeded care, as well as identifying and treating clinical trial participants.

Our global Clinical department consists of colleagues with institutionalknowledge, in-depth therapeutic experience, and robust operational tools.Together, we help clients define and develop clinical programs, minimize delaysand execute high-quality, cost-efficient clinical studies.

Mainresponsibilities



As a PPD CRA, youwill perform and coordinate all aspects of the clinical monitoring and sitemanagement process. TheCRAs conduct remote or on-site visits to assess protocol and regulatorycompliance and manage required documentation. They manage procedures and guidelinesfrom different sponsors and/or monitoring environments. Part of theresponsibilities is to act as a site processes specialist, ensuring that thetrial is conducted in accordance with the approved protocol, ICH-GCPguidelines, applicable regulations and SOPs to guarantee subjects rights,well-being and data reliability. They also ensure audit readiness and developcollaborative relationships with investigational sites. In addition, someresponsibilities also include:

• Providingtrial status tracking and progress update reports to the Clinical Team Manager(CTM) as required. Ensures study systems are updated per agreed studyconventions (e.g. Clinical Trial Management System, CTMS). Performs QC check ofreports generated from CTMS system where required.

• Participationin investigator meetings as necessary. Identifies potential investigators incollaboration with the client company to ensure the acceptability of qualifiedinvestigative sites. Initiates clinical trial sites according to the relevantprocedures to ensure compliance with the protocol and regulatory and ICH GCPobligations, making recommendations where warranted. Ensures trial close outand retrieval of trial materials.

• Ensuresthat required essential documents are complete and in place, according toICH-GCP and applicable regulations. Conducts on-site file reviews as perproject specifications.

• Contributesto the project team by assisting in preparation of project publications/toolsand sharing ideas/suggestions with team members. Performs additional studytasks as assigned by CTM (e.g. trip report review, newsletter creation, leadCRA team calls etc).

Job Qualification:

Requirements
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.

PPD Defining Principles:



- We 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.

Diversity Statement

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

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