Clinical Research Associate 2 - IQVIA Biotech

IQVIA; United States; Remote; USD 47.000 - 74.000; Vollzeit

Zusammenfassung

IQVIA Biotech is seeking a Clinical Research Associate to monitor sites across multiple therapeutics. The role is home-based in Spain, requiring travel, and collaboration with study teams to ensure GCP/ICH compliance and data integrity.

The ideal candidate will have 1.5+ years in on-site monitoring, a science or healthcare degree, and strong organizational and communication skills. This position offers a remote work arrangement within Spain.

Qualifikationen

• Bachelor’s degree preferred in science or healthcare.
• At least 1.5 years of on-site monitoring experience.
• Equivalent mix of education, training and experience accepted.
• Strong organizational and time-management abilities.
• Ability to build effective working relationships with teams and clients.
• Travel flexibility and a valid driver's license.

Aufgaben

• Perform site monitoring visits per scope and GCP/ICH guidelines.
• Support subject recruitment plans aligned with project needs.
• Administer protocol training to sites and maintain communication.
• Evaluate site practices for protocol and regulatory compliance.
• Track regulatory submissions, recruitment, CRF, and data queries.
• Ensure TMF/ISF filing and document control.
• Draft visit reports and follow-up correspondence.
• Collaborate with study team for project execution.
• Possibly support recruitment plans per site and site financials.

Kenntnisse

On-site monitoring

Time management

Problem solving

Relationship building

Travel flexibility

Communication skills

Driver's license

Ausbildung

Bachelor’s Degree in scientific discipline or health care

Jobbeschreibung

IQVIA Biotech is hiring Clinical Research Associate in Spain!

IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.

The ideal candidate will have varied therapeutic experience and be willing to working across multiple therapeutics including: Oncology, Hematology, Cardiovascular, etc. This role will be home-based in Spain.

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) 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

• 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

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 https://jobs.iqvia.com.

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.

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 and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.