IQVIA
ClinicalResearchAssociate
“Clinical Research Associate at IQVIA. Skills: monitoring, site management, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines. 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.. Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contrac”
Industry & Context.
Organizational and problem-solving skills.
What They're Looking For.
Must Have
Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i. e. , Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)., Computer skills including proficiency in use of Microsoft 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.
Nice to Have
Degree in scientific discipline or health care preferred., Equivalent combination of education, training and experience may be accepted in lieu of degree., Some organizations require completion of CRA training program or prior monitoring experience., Good therapeutic and protocol knowledge as provided in company training.
What You'll Do.
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.
Perform site monitoring visits (selection
monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements
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.
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.
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.
Support development of project subject recruitment plan on a per site basis.
Support site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
How You'll Work.
Team & Collaboration
Collaborate and liaise with study team members for project execution support as appropriate.; Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Communication Scope
Written and verbal communication skills; good command of English language
Process & Methodology
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.
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