Clinical Research Associate, Sponsor Dedicated at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Clinical Research, Healthcare, PharmaceuticalsIndustries

Requirements

Bachelor’s Degree in a scientific discipline or healthcare field preferred
At least 2 years of on-site monitoring experience
Good knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Good therapeutic and protocol knowledge (as provided in company training)
Proficiency in Microsoft Word, Excel, and PowerPoint
Experience with laptop computers, iPhone, and iPad (where applicable)
Strong written and verbal communication skills in English
Organizational and problem-solving skills
Effective time and financial management skills

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring, and close-out) in accordance with the contracted scope of work and GCP guidelines
Work with sites to adapt, drive, and track subject recruitment plans to enhance predictability
Administer protocol and study training to assigned sites and establish regular communication lines
Evaluate the quality and integrity of study site practices, escalating quality issues as needed
Track regulatory submissions, recruitment, CRF completion, and data query resolution
Create and maintain site management documentation, including visit reports and action plans
Collaborate with study team members for project execution support
Support the development of a per-site subject recruitment plan (if applicable)
Manage site financial management according to the clinical trial agreement and retrieve invoices (if applicable)

Skills

Key technologies and capabilities for this role

GCPICHMicrosoft WordMicrosoft ExcelMicrosoft PowerPointSite MonitoringCRF CompletionData Query ResolutionProtocol TrainingRegulatory Submissions

Questions & Answers

Common questions about this position

What is the salary for this Clinical Research Associate position?

This information is not specified in the job description.

Is this Clinical Research Associate role remote or onsite?

The position is onsite.

What skills are required for this Clinical Research Associate role?

Required skills include good knowledge of Good Clinical Practice (GCP) and ICH guidelines, proficiency in Microsoft Word, Excel, and PowerPoint, strong written and verbal communication skills in English, and organizational and problem-solving skills.

What experience is needed for this position?

At least 2 years of on-site monitoring experience is required, along with a Bachelor’s Degree in a scientific discipline or healthcare field preferred.

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

A strong candidate will have at least 2 years of on-site monitoring experience, knowledge of GCP and ICH guidelines, proficiency in Microsoft Office tools, and strong communication, organizational, and problem-solving skills.

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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