Sponsor‑Dedicated Clinical Research Associate (CRA)

IQVIA; Littleton (CO); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking a field-based monitoring professional in the United States to ensure sites conduct studies per protocol and regulatory requirements. You will manage site visits, training, and communication with sites to maintain study timelines and data quality.

The role requires on-site monitoring experience, familiarity with GCP/ICH, and strong organizational, time-management, and English communication skills. Equal opportunity employer; competitive compensation and benefits apply.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 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 MS 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 monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Drive 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.
• Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution.
• Ensure copies/originals site documents are available for TMF filing and ISF maintained per GCP and local regulations.
• Create and maintain documentation regarding site management, visit findings and action plans.
• Collaborate with study team members for project execution support.
• May support development of project subject recruitment plan on a per site basis.
• May be accountable for site financial management per clinical trial agreement and retrieve invoices per local requirement.

Skills

Communication skills

English proficiency

Organizational skills

Problem-solving

Time management

Interpersonal skills

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Excel

PowerPoint

Laptop usage

Mobile device usage (iPhone/iPad)

Job description

IQVIA is seeking a field-based monitoring professional in the United States to ensure sites conduct studies per protocol and regulatory requirements. You will manage site visits, training, and communication with sites to maintain study timelines and data quality.

The role requires on-site monitoring experience, familiarity with GCP/ICH, and strong organizational, time-management, and English communication skills. Equal opportunity employer; competitive compensation and benefits apply.