Clinical Research Associate (CRA/Sr CRA) - Sponsor dedicated - Hungary at IQVIA

Budapest, Hungary

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, PharmaceuticalsIndustries

Requirements

Bachelor's degree, scientific discipline or health care preferred
1+ years of on-site monitoring experience
Good therapeutic and protocol knowledge
IT literate
Written and verbal communication skills including good command of English and Hungarian language
Organizational and problem-solving skills
Effective time and financial management skills
Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Located in Hungary

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring and close-out visits)
Work with sites to adapt, drive and track subject recruitment plan in line with project needs
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
Ensure site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
Collaborate and liaise with study team members for project execution support as appropriate
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

Skills

Key technologies and capabilities for this role

GCPICHSite MonitoringCRFTMFISFProtocol TrainingRegulatory ComplianceSubject RecruitmentClinical Trial Management

Questions & Answers

Common questions about this position

What experience is required for the Clinical Research Associate position?

A Bachelor's degree in a scientific discipline or health care is preferred, along with 1+ years of on-site monitoring experience.

What key skills are needed for this CRA role?

Candidates need good therapeutic and protocol knowledge, IT literacy, written and verbal communication skills in English and Hungarian, organizational and problem-solving skills, effective time and financial management skills, and the ability to establish effective working relationships.

Where is this position located?

The position requires candidates to be located in Hungary.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this CRA position at IQVIA?

Strong candidates will have a Bachelor's degree in a scientific or health care field, at least 1 year of on-site monitoring experience, fluency in English and Hungarian, and skills in communication, organization, problem-solving, and relationship-building, while being located in Hungary.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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