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IQVIA · 2 hours ago

Clinical Research Associate - Sponsor Dedicated

Parsippany, NJ

Full-time

Onsite

Entry Level

$58K/yr - $227K/yr

1+ years exp

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The role involves performing monitoring and site management work to ensure compliance with study protocols and regulations while managing site recruitment and data integrity.

AnalyticsHealth CareLife Science

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice

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

Qualification

Clinical ResearchClinical Practice (GCP)International Conference on Harmonization (ICH)Site Monitoring ExperienceMicrosoft Office SuiteFinancial ManagementRelationship ManagementWritten CommunicationVerbal CommunicationOrganizational SkillsProblem-Solving SkillsTime Management

Required

Requires at least 1.5 years 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