Clinical Trial Nurse - Norwich, CT at IQVIA

Norwich, Connecticut, United States

IQVIA Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Part TimeJob Type
UnknownVisa
Healthcare, Clinical Trials, PharmaceuticalIndustries

Requirements

  • Knowledge of study protocols, source document forms, electronic data capture systems, Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) principles, sponsor SOPs, and relevant local guidelines/regulations
  • Ability to perform complex clinical research procedures including ECG, lab sample collection, spirometry, vital signs, dose verifications, cardiac telemetry monitoring, and questionnaire administration
  • Skills in lab testing, specimen collection preparation, and lab logistics
  • Up-to-date knowledge of current best nursing practices and clinical research topics
  • Adherence to site policies, SOPs, FDA requirements, and clinical research regulations
  • Ability to provide training, guidance, and supervision to site staff

Responsibilities

  • Provide clinical research support to investigators for study preparation and execution
  • Review study protocols, source documents, and electronic data capture systems
  • Collect and submit regulatory/ethics documentation to FDA and other bodies
  • Recruit and screen patients, maintain screening/enrollment logs
  • Orient research subjects to study purpose, procedures, and requirements
  • Maintain source documentation per GCP/ICH principles
  • Schedule and execute study visits and procedures as delegated by Principal Investigator
  • Handle lab testing, specimen collection, and lab logistics
  • Monitor subject safety, report adverse events to Principal Investigator, team, and IRBs
  • Correspond with subjects to address study-related questions/concerns
  • Participate in meetings with site staff and Investigators to assign and execute tasks
  • Perform data quality checking and query resolution
  • Update and maintain site staff skills, training records, and knowledge
  • Assist investigators in safeguarding subject well-being and maintaining research standards
  • Maintain a safe environment and act as advocate for research subjects
  • Address subject questions proactively and take remedial action
  • Advise site staff on nursing practices and study care delivery
  • Report deviations from research practices and implement changes
  • Assist in verifying study objectives are met on time, within budget, per protocol and regulations
  • Provide training to new site staff on study-specific topics
  • Audit and maintain staff training records
  • Provide guidance/supervision to lower-level staff per protocols/SOPs
  • Participate in study process reviews, enhancements, budget control, and team development
  • Prepare for and attend study monitoring visits, audits, and regulatory inspections
  • Assist with staffing and scheduling coverage for research projects

Skills

Clinical Research
GCP
ICH
Patient Recruitment
Screening
Source Documentation
Study Visits
Lab Testing
Adverse Event Reporting
ECG
Protocol Review
Regulatory Documentation
FDA

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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