Iqvia
Life Sciences
SrCRA1
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr CRA 1 at Iqvia. Skills: site monitoring, clinical research, regulatory requirements. Perform monitoring and site management. Ensure sites conduct study as required”
What You'll Achieve.
ensure that sites are conducting the study(ies) and reporting study data as required
Industry & Context.
Organizational and problem-solving skills
What They're Looking For.
Must Have
Bachelor's Degree in scientific discipline or health care, at least 2 years of year of on-site monitoring experience, applicable clinical research regulatory requirements, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, Computer skills, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, laptop computer, iPhone, iPad, Written and verbal communication skills, English language, Organizational skills, problem-solving skills, Effective time management skills, Effective financial management skills
Nice to Have
Good therapeutic knowledge, Good protocol knowledge
What You'll Do.
Perform monitoring and site management
Ensure sites conduct study as required
Perform site monitoring visits
Adapt subject recruitment plan
Administer protocol and study training
Establish communication with sites
Evaluate quality and integrity of site practices
Escalate quality issues
Manage study progress
Track regulatory submissions
Track recruitment and enrollment
Track data query resolution
Ensure site documents are filed
Verify Investigator's Site File maintenance
Create site management documentation
Submit regular visit reports
Generate follow-up letters
Collaborate with study team members
Support development of recruitment plan
Support site financial management
How You'll Work.
Team & Collaboration
Collaborate and liaise with study team members; Establish and maintain effective working relationships with coworkers, managers, and clients
Communication Scope
Written communication skills; Verbal communication skills; English language; Good command of English language
Process & Methodology
Manage the progress of assigned studies, track regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, data query generation and resolution, site financial management
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 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, 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) and verify that the Investigator's Site File (ISF) is maintained 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. Qualifications • Ba
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