Clinical Research Associate, Slovakia

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Division Specific Information:

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.

Discover Impactful Work:

As an Assistant CRA in our site in Šamorín, Slovakia, you will use a variety of tools and technologies to review study data. You will interact with study sites via phone, supporting the site teams and monitoring subject enrollment for the study. In this position you embody ethical research and business conduct, ensuring we never compromise quality or patient safety.

Responsibilities:

• Completes study and site management activities as defined in task matrix, and as applicable for study assigned.
• Completes and documents study-specific training.
• Orients and trains on any CRG/study-specific systems.
• Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
• Supports to customize Site ICF with site contact details, as needed.
• Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments and centralized monitoring tools.
• Verifies document collection and RCR submission status; updates site EDL and verifies site information; status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as per needs. .
• Reviews patient facing materials and review translations, if needed.
• Supports site staff with the vendor related qualification process, where applicable.
• Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation phase and the subsequent course of the study.
• Provides support to follow-up on site staff training, as applicable.
• Coordinates and supports logistics for IM attendance.
• Supports maintenance of vendor trackers.
• Coordinates study/site supply management during pre-activation and subsequent course of the study.
• Supports Essential Document collection, review and updating in systems, as applicable.
• Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries.
• Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, if requested and follows-up on site invoices throughout the study period.
• Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
• May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix.
• May perform a specific role profile for FSP opportunities according to Client requests.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Education:

• Bachelor’s Degree in a life science-related field OR Registered Nurse license along with an Associate’s Degree in Nursing.

Experience:

• Prior clinical research experience 1-2 years as well as knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities. In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care or background in a health sciences field with formal training in medical terminology and anatomy may be considered.

Knowledge, Skills, Abilities:

• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain an understanding of ICH GCPs, applicable regulations and PPD procedural documents.
• Ability to evaluate medical research data.
• Ability to advise, counsel, and empower investigational sites.
• Excellent local and English language and grammar skills, as well as local language proficiency.
• Effective oral and written communication skills with the ability to communicate effectively with medical personnel.
• Excellent interpersonal and customer service skills.
• Good organizational and time-management skills.
• Shown flexibility and adaptability.
• Strong attention to detail.
• Ability to work in a team or independently, as required.
• Well-developed critical thinking skills: critical mentality, in-depth investigation for appropriate root cause analysis and problem solving.
• Ability to coach and mentor site personnel.
• Good digital literacy with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable.
• Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards.

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 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 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. 

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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