CRA 2, Internal Medicine/Cell & Gene Therapy, U.S. - IQVIA Biotech at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s Degree in a scientific discipline or healthcare field preferred
Minimum of 1 year of on-site monitoring experience in Internal Medicine, CNS, or Cardiovascular fields
Experience in Cell & Gene Therapy
Good knowledge of and skill in applying Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Therapeutic and protocol knowledge (as provided in company training)
Proficiency in Microsoft Word, Excel, and PowerPoint
Experience using a laptop computer, iPhone, and iPad (where applicable)

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring, and close-out) in accordance with the scope of work and regulatory requirements
Work with sites to adapt, drive, and track subject recruitment plans
Administer protocol and study training to assigned sites and maintain regular communication
Evaluate site practices related to protocol conduct and adherence to regulations
Escalate quality issues as appropriate
Manage study progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution
Ensure site documents are available for the Trial Master File (TMF) and Investigator’s Site File (ISF) are maintained
Create and maintain site management documentation, including visit reports and follow-up letters
Collaborate with study team members for project execution support
Support the development of project subject recruitment plans (if applicable)
Manage site financial management according to the clinical trial agreement and retrieve invoices (if applicable)

Skills

GCP

ICH

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

On-site Monitoring

Site Management

Protocol Training

CRF Completion

TMF

ISF

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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