IQVIA
life sciences and healthcare
SrCRA1
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr CRA 1 at IQVIA. Skills: monitoring activities, site management, GCP, ICH guidelines, oncology clinical trials. Perform high‑quality monitoring activities and site management. Ensure clinical sites conduct studies in full compliance with the protocol, ICH‑GCP guidelines, regulatory requirements, and sponsor expectations”
What You'll Achieve.
meet project timelines and enrollment targets; safeguard data integrity, patient safety, and overall study performance
Industry & Context.
problem‑solving abilities; resolve issues proactively
What They're Looking For.
Must Have
Bachelor’s degree in a scientific or healthcare‑related field, Minimum of 4 years of on‑site monitoring experience, Solid understanding of clinical research regulations, including GCP and ICH guidelines, Proficiency with Microsoft Word, Excel, PowerPoint, and mobile technology (laptop, iPhone, iPad where applicable), Excellent written and verbal communication skills, including command of the English language, organizational, problem‑solving, and time‑management abilities, Ability to build and maintain effective working relationships with colleagues, site staff, managers, and clients, Demonstrated ability to work independently, manage multiple priorities, and maintain high‑quality standards
Nice to Have
Strong interest and/or hands‑on experience in oncology clinical trials, prior involvement in oncology studies
What You'll Do.
Perform high‑quality monitoring activities and site management
Ensure clinical sites conduct studies in full compliance with the protocol
regulatory requirements
and sponsor expectations
Safeguard data integrity
and overall study performance
Conduct site monitoring visits (selection
Partner with sites to develop
and track recruitment strategies
Deliver protocol and study‑specific training to site
Maintain consistent communication to manage expectations and resolve issues proactively
Assess the quality and integrity of site practices
Escalate quality concerns when necessary
including regulatory submissions
Support start‑up activities
Ensure essential documents are complete and properly filed in the Trial Master File (TMF) and that the Investigator Site File (ISF) meets GCP and local regulatory standards
Document all site management and monitoring activities through visit reports
and required study documentation
Collaborate with cross‑functional study team members to support project execution
Support development of site‑level recruitment plans
Manage site financial activities according to the clinical trial agreement
How You'll Work.
Team & Collaboration
Collaborate with cross‑functional study team members to support project execution; Ability to build and maintain effective working relationships with colleagues, site staff, managers, and clients
Communication Scope
Excellent written and verbal communication skills; command of the English language; Maintain consistent communication
Process & Methodology
manage multiple priorities
Full Job Description
## **Job Overview** The Sr Clinical Research Associate (CRA) is responsible for performing high‑quality **monitoring activities** and site management to ensure that clinical sites conduct studies in full compliance with the protocol, ICH‑GCP guidelines, regulatory requirements, and sponsor expectations. This role plays a key part in safeguarding data integrity, patient safety, and overall study performance. ## **Essential Functions** * Conduct site monitoring visits (selection, initiation, routine monitoring, and close‑out) in alignment with the contracted scope of work and Good Clinical Practice. * Partner with sites to develop, adapt, and track recruitment strategies to meet project timelines and enrollment targets. * Deliver protocol and study‑specific training to site personnel; maintain consistent communication to manage expectations and resolve issues proactively. * Assess the quality and integrity of site practices, ensuring adherence to protocol and regulatory requirements; escalate quality concerns when necessary. * Track study progress, including regulatory submissions, approvals, enrollment metrics, CRF completion, and data query resolution; may support start‑up activities. * Ensure essential documents are complete and properly filed in the Trial Master File (TMF) and that the Investigator Site File (ISF) meets GCP and local regulatory standards. * Document all site management and monitoring activities through visit reports, follow‑up letters, and required study documentation. * Collaborate with cross‑functional study team members to support project execution. * When applicable, support development of site‑level recruitment plans and manage site financial activities according to the clinical trial agreement. ## **Qualifications** * Bachelor’s degree in a scientific or healthcare‑related field preferred; equivalent education, training, and experience may be considered. * **Minimum of 4 years of on‑site monitoring experience** required. * **Strong interest
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