Clinical Trials Monitoring Specialist

IQVIA; Ainsworth (NE); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate (CRA) to monitor sites per protocol and GCP in the United States. You will work with investigative sites to manage recruitment plans, training, and documentation to ensure data integrity and regulatory compliance.

The role requires at least 2 years of on-site monitoring experience, proficiency in EDC/CTMS/eTMF, and strong communication and organizational skills. This is a largely on-site position with collaboration across study teams.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of independent on-site monitoring experience as a CRA in a CRO, sponsor, or similar setting.
• 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 ICH guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Must have experience utilizing EDC, CTMS, eTMF, IVRS/IWRS, and other clinical trial systems in support of monitoring activities.
• 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 per protocol and Good Clinical Practice.
• Support subject recruitment planning to improve predictability.
• Administer protocol training and maintain site communications.
• Ensure site documents are filed in TMF and ISF kept per regs.
• Create documentation of monitoring findings and action plans.
• Collaborate with study team for project execution.
• May support start-up phase and site financial management where applicable.

Skills

On-site monitoring

English proficiency

Communication skills

Organizational skills

Time management

Education

Bachelor's degree in scientific discipline or health care

Tools

Microsoft Word

Excel

PowerPoint

EDC

CTMS

eTMF

IVRS/IWRS

Job description

IQVIA is seeking a Clinical Research Associate (CRA) to monitor sites per protocol and GCP in the United States. You will work with investigative sites to manage recruitment plans, training, and documentation to ensure data integrity and regulatory compliance.

The role requires at least 2 years of on-site monitoring experience, proficiency in EDC/CTMS/eTMF, and strong communication and organizational skills. This is a largely on-site position with collaboration across study teams.