Clinical Research Associate II, Ireland at IQVIA

Dublin, County Dublin, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, Clinical ResearchIndustries

Requirements

Experience of independent on-site monitoring (2 years+) on Oncology studies
In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Life science degree educated or equivalent industry experience
Flexibility to travel to sites as required

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
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. May support start-up phase
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP 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

Skills

Key technologies and capabilities for this role

On-site MonitoringGood Clinical PracticeOncology StudiesSite InitiationProtocol TrainingRegulatory SubmissionsCRF CompletionData Query ResolutionTrial Master FileInvestigator Site FileSubject Recruitment

Questions & Answers

Common questions about this position

What salary is offered for the Clinical Research Associate II position?

This information is not specified in the job description.

Is this Clinical Research Associate role remote or office-based?

This information is not specified in the job description.

What are the key requirements for this CRA II position?

Candidates need 2+ years of independent on-site monitoring experience on Oncology studies, in-depth knowledge of Good Clinical Practice (GCP) and ICH guidelines, and a life science degree or equivalent industry experience. Flexibility to travel to sites across Ireland (with occasional UK travel) is also required.

What is the work arrangement and travel involved in this role?

The role is full-time and involves performing site monitoring visits across sites in Ireland, with occasional travel to the UK.

What makes a strong candidate for this Clinical Research Associate position?

Strong candidates will have at least 2 years of independent on-site monitoring experience specifically on Oncology studies, deep GCP and ICH knowledge, a life sciences degree, and flexibility for site travel.

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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