Senior Clinical Research Associate at IQVIA

Reading, England, United Kingdom

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, PharmaceuticalIndustries

Requirements

A minimum of 18 months of independent on-site monitoring
Successfully managed multiple clinical trial protocols across diverse investigative sites
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

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
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

GCPICH guidelinessite monitoringprotocol trainingsubject recruitmentregulatory submissionsCRF completionclinical trial management

Questions & Answers

Common questions about this position

What experience is required for the Senior Clinical Research Associate role?

A minimum of 18 months of independent on-site monitoring is required, along with successfully managing multiple clinical trial protocols across diverse investigative sites.

What are the key responsibilities of a Clinical Research Associate at IQVIA?

Responsibilities include performing site monitoring visits in accordance with GCP and ICH guidelines, driving subject recruitment plans, evaluating site practices, managing study progress, and maintaining documentation like visit reports and the Trial Master File.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this a remote position or does it require travel?

The role requires flexibility to travel to sites and involves independent on-site monitoring visits.

What education or qualifications are needed for this role?

Candidates need a life science degree or equivalent industry experience, plus in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

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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