Sponsor-Driven Clinical Research Associate

IQVIA; Belmar (NJ); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA in Belmar, New Jersey seeks an experienced Clinical Site Monitor to ensure studies are conducted per protocol, GCP, and sponsor requirements.

The role involves performing site visits, driving subject recruitment plans, administering protocol training, maintaining site communications, and tracking regulatory submissions, enrollments, CRFs, and data queries. Collaboration with study teams is essential to keep trials on track.

Qualifications

• Bachelor's degree in a scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (GCP/ICH).
• Computer skills including MS Word, Excel and PowerPoint; familiarity with laptops and iOS devices.
• Written and verbal communication skills including English language proficiency.
• Strong organizational and problem-solving abilities.

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, 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 TMF and verify ISF maintenance 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

On-site monitoring

English communication

Time management

Financial management

Relationship building

Regulatory knowledge

Education

Bachelor's degree in a scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

PowerPoint

iPhone/iPad usage

Job description

IQVIA in Belmar, New Jersey seeks an experienced Clinical Site Monitor to ensure studies are conducted per protocol, GCP, and sponsor requirements.

The role involves performing site visits, driving subject recruitment plans, administering protocol training, maintaining site communications, and tracking regulatory submissions, enrollments, CRFs, and data queries. Collaboration with study teams is essential to keep trials on track.