Clinical Research Associate - Sponsor Dedicated at IQVIA

Parsippany, New Jersey, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

Bachelor's Degree in scientific discipline or health care preferred
At least 1 year of on-site monitoring experience
Equivalent combination of education, training and experience may be accepted in lieu of degree
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
Good therapeutic and protocol knowledge as provided in company training
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
Written and verbal communication skills including good command of English language
Organizational and problem-solving skills
Effective time and financial management skills
Ability to establish and maintain effective working relationships with coworkers, managers, and clients

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
Collaborate and liaise with study team members for project execution support as appropriate
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

Skills

Key technologies and capabilities for this role

GCPICH guidelinesSite MonitoringProtocol TrainingSubject RecruitmentRegulatory SubmissionsCRF CompletionData Query ResolutionTMF ManagementISF Maintenance

Questions & Answers

Common questions about this position

What education and experience are required for this Clinical Research Associate role?

A Bachelor's Degree in a scientific discipline or health care is preferred, with at least 1 year of on-site monitoring experience required. An equivalent combination of education, training, and experience may be accepted in lieu of a degree.

What key skills are needed for this position?

Candidates need good knowledge of clinical research regulatory requirements like GCP and ICH guidelines, computer skills including proficiency in Microsoft Word, Excel, and PowerPoint, strong written and verbal communication skills in English, organizational and problem-solving skills, and effective time and financial management skills.

Is this a remote position or does it require on-site work?

The role requires at least 1 year of on-site monitoring experience and involves performing site monitoring visits, indicating significant on-site work at clinical trial sites.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this Clinical Research Associate position?

Strong candidates will have a scientific or health care degree, at least 1 year of on-site monitoring experience, knowledge of GCP and ICH guidelines, proficiency in Microsoft Office tools, and excellent 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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