Senior/Clinical Research Associate(Beijing/Shanghai/Guangzhou/Other Cities) at IQVIA

Shanghai, Shanghai, China

IQVIA Logo
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

GCP
ICH guidelines
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Site Monitoring
Clinical Trial Management
Regulatory Compliance
Protocol Training
Data Query Resolution
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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