Clinical Research Coordinator at IQVIA

Mumbai, Maharashtra, India

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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, Life Sciences, HealthcareIndustries

Requirements

Knowledge of clinical trial processes, including site feasibility, regulatory submissions, and ethical guidelines
Ability to review patient databases, pre-screening, and identify physician networks
Familiarity with clinical trial supplies management (receipt, accountability, storage, dispensing)
Understanding of informed consent processes and patient information sheets
Proficiency in CRF completion, query resolution, and documentation maintenance
Experience coordinating lab samples, logistics, and reporting
Skills in recruitment/referral activities and patient enrollment
Capability to manage monitoring visits, audits, and resolution of findings
Knowledge of patient follow-up, compliance, reimbursements, and site payments
Adherence to protocol guidelines, regulations, and timely stakeholder reporting

Responsibilities

Conduct site/trial feasibility to identify and select the right site and investigator
Ensure timely compilation of essential documents, assist in regulatory package preparation, submission, follow-up with site EC, and obtain approvals
Ensure site setup according to protocol, review patient database, pre-screening, and identify physician network
Coordinate receipt, accountability, and storage of clinical trial supplies
Prepare site team for study initiation visit and coordinate with monitor
Assist in administering informed consent to potential subjects and discussing patient information sheet
Ensure site documentation remains current, accurate, and complete
Coordinate lab samples collection and logistics; review lab reports and update PI
Review and implement recruitment/referral activities for active enrollment
Ensure CRF completion and query resolution on specified timelines
Coordinate monitoring visits and audits (internal or external)
Ensure resolution of monitoring/audit findings within timelines
Ensure patient follow-up visits and compliance; manage patient and site payments/reimbursements
Manage drug receipt, accountability, storage, dispensing, and documentation
Ensure adherence to protocol guidelines, regulations, and ethical guidelines
Coordinate and ensure timely reporting to all stakeholders
Maintain study log(s) and study manuals
Assist monitor with site closeout activities
Manage final reconciliation of clinical trial supplies and archival of study documents

Skills

Key technologies and capabilities for this role

Site FeasibilityRegulatory SubmissionsEC ApprovalsSite SetupPatient RecruitmentInformed ConsentCRF CompletionQuery ResolutionMonitoring VisitsLab LogisticsProtocol AdherenceClinical Trial SuppliesStudy DocumentationPatient Follow-upICH-GCP

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time employment opportunity.

What is the salary range for the Clinical Research Coordinator role?

This information is not specified in the job description.

Is remote work available for this position?

This information is not specified in the job description.

What key responsibilities are required for this role?

Key responsibilities include conducting site/trial feasibility, ensuring timely compilation of essential documents and regulatory submissions, coordinating clinical trial supplies, patient recruitment, CRF completion, query resolution, and adherence to protocol guidelines.

What is IQVIA's mission as a company?

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, creating intelligent connections to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes.

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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