IQVIA
CRA1
Neural analysis suggests this role is
optimal for Mid+ candidates.
“CRA 1 at IQVIA. Skills: Site monitoring, Clinical research, Regulatory requirements. Perform site monitoring visits. Adapt subject recruitment plan”
Industry & Context.
Problem-solving skills
What They're Looking For.
Must Have
Bachelor's Degree in scientific discipline or health care, Basic knowledge of applicable clinical research regulatory requirements, Good therapeutic and protocol knowledge, Proficiency in Microsoft Word, Excel and PowerPoint, Proficiency in use of a laptop computer and iPhone and iPad, Written and verbal communication skills, Good command of English language, Organizational and problem-solving skills, Effective time and financial management skills, Ability to establish and maintain effective working relationships
Nice to Have
Completion of CRA training program, Prior monitoring experience
What You'll Do.
Perform site monitoring visits
Adapt subject recruitment plan
Drive subject recruitment plan
Track subject recruitment plan
Administer protocol training
Administer study training
Establish communication with sites
Manage project expectations
Manage project issues
Evaluate quality of site practices
Evaluate integrity of site practices
Escalate quality issues
Manage study progress
Track regulatory submissions
Track regulatory approvals
Track data query generation
Track data query resolution
Support start-up phase
Ensure site documents are available
File site documents in TMF
Verify Investigator's Site File maintenance
Create site management documentation
Create monitoring visit findings documentation
Create action plan documentation
Submit regular visit reports
Generate follow-up letters
Generate study documentation
Collaborate with study team members
Liaise with study team members
Support project execution
Support development of recruitment plan
Support site financial management
How You'll Work.
Team & Collaboration
Study team members
Communication Scope
Written communication; Verbal communication; English language
Full Job Description
Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • 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) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH 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 execut
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