Job detail

Clinical Research Associate, Sponsor Dedicated

IQVIA

#Monitoring #GCP #Regulatory Submissions #Life Sciences #ICH #Trial Master File #Site Management #IQVIA #Electronic Data Capture

Quick overview

Perform site monitoring and management to ensure study compliance with protocols, regulations, and sponsor requirements. Manage study progress, including regulatory submissions, recruitment tracking, and data integrity verification.

Requirements summary

Requires at least 2.5 years of clinical research coordination experience at the site level. Candidates must hold a Bachelor's degree or equivalent in a life science field.

bachelor degreeGCPClinical researchSite managementRegulatory submissionsGood clinical practiceSite monitoringICH guidelinesSubject recruitmentElectronic data captureData query resolutionTrial master fileProtocol trainingInvestigator site fileClinical trial agreementSite financial management

Job description

To be eligible for this position, you must reside in the same country where the job is located. Seeking experienced candidates near major hub airports in the Southeast, Northeast, Central and West regions. 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. Position requires 65-70% nationwide travel. 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 executed clinical trial agreement and retrieve invoices according to local requirement. MINIMUM RECRUITMENT STANDARDS: 2.5 years of clinical research coordination experience at site level Nursing or University Degree (US Bachelor Level or equivalent) in one of the life sciences Knowledge of electronic data capture preferred Equivalent combination of education, training and experience IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $64,000.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

Clinical Research Associate, Sponsor Dedicated

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