Other Cities) at IQVIA

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Junior (1 to 2 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor’s Degree in a scientific discipline or healthcare (preferred)
At least 1 year of on-site monitoring experience (required)
Good knowledge of 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)
Strong written and verbal communication skills in English
Organizational and problem-solving skills
Effective time and financial management skills

Responsibilities

Conduct site monitoring visits (selection, initiation, monitoring, and close-out) adhering to contracted scope of work and regulatory requirements
Work with sites to adapt, drive, and track subject recruitment plans to enhance predictability
Administer protocol training to sites and maintain regular communication to manage project expectations
Evaluate site practices related to protocol conduct and adherence to regulations, escalating quality issues as needed
Track regulatory submissions, recruitment, CRF completion, and data query resolution; support the start-up phase
Ensure site documents are available for the Trial Master File (TMF) and Investigator’s Site File (ISF) are maintained according to GCP and local regulations
Create and maintain site management documentation, including visit reports, follow-up letters, and study documentation
Collaborate with study team members for project support
Support the development of project subject recruitment plans on a per-site basis (potentially accountable)
Manage site financial management according to the clinical trial agreement and retrieve invoices (potentially accountable)

Skills

Key technologies and capabilities for this role

GCPICH guidelinesMicrosoft WordMicrosoft ExcelMicrosoft PowerPointSite MonitoringClinical Trial ManagementRegulatory ComplianceProtocol TrainingData Query ResolutionTMFISF

Questions & Answers

Common questions about this position

What is the salary for this Senior/Clinical Research Associate position?

This information is not specified in the job description.

Is this role remote or onsite, and where is it located?

The position is onsite and located in Beijing, Shanghai, Guangzhou, or other cities.

What skills and experience are required for this role?

Requirements include at least 1 year of on-site monitoring experience, good knowledge of GCP and ICH guidelines, proficiency in Microsoft Word, Excel, and PowerPoint, and strong English communication, organizational, and problem-solving skills.

What education is needed for this Clinical Research Associate position?

A Bachelor’s Degree in a scientific discipline or healthcare is preferred.

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

Strong candidates will have at least 1 year of on-site monitoring experience, knowledge of GCP and ICH guidelines, proficiency in Microsoft Office tools, and excellent English 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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