Clinical Research Associate 2
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Job Description
Clinical Research Associate conducting site monitoring visits for IQVIA Biotech in Spain. Monitoring compliance with regulatory requirements and managing ongoing project expectations at study sites.
Responsibilities:
- 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) 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.
Requirements:
- Bachelor's Degree in scientific discipline or health care preferred
- Requires at least 1.5 years of on-site monitoring experience
- Equivalent combination of education, training and experience may be accepted
- Organizational, time management and problem-solving skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Flexibility to travel
- Driver’s license
Benefits:
- IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.
- We appreciate your honesty and professionalism.
- At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide.
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