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Clinical Research Associate, Slovakia

PPD Czech Republic, s.r.o.

Information about the position

  • Place of work: Bratislavská 2110/100D, Šamorín, Slovakia (Job with occasional home office)
  • Basic wage component (gross) and other rewards: Competetive
  • Contract type: full-time

Job description, responsibilities and duties


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.

Employee perks, benefits

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.

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)

Language skills

English - Advanced (C1) and Slovak - Advanced (C1)

Personality requirements and skills


· Bachelor's degree in a life science related field.


· Minimum 1+ year of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organization.

· Clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical 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:

· Local language as well as good level of proficiency in English.

· Valid driver's license where applicable.

· Basic medical/therapeutic area knowledge and understanding of medical terminology.

· Ability to attain and maintain a knowledge of ICH GCPs and applicable regulations and procedural documents.

· Good oral and written communication skills, needed to communicate effectively with medical personnel.

· Good social skills and ability to maintain customer-faced focus through the utilization of good listening skills, attention to detail and ability to perceive customers’ underlying issues.

· Good organizational and time-management skills.

· Ability to remain flexible and adaptable in a wide range of scenarios.

· Well-developed critical thinking skills, including but not limited to: critical mentality, in-depth investigation for appropriate root cause analysis and problem solving.

· Ability to run Risk Based Monitoring concepts and processes.

· Ability to work in a team or independently as required.

· Good digital literacy: proven knowledge of Microsoft Office.


Brief description of the company

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.

Number of employees

1000 and more employees