Senior Clinical Research Associate

This is a fully remote position, open to applicants in Spain.

📋 Description

• Independently conduct responsibilities related to site monitoring for clinical trials.

• Provide oversight, leadership, and guidance in the management and execution of clinical trials.

• Ensure adherence to protocols and maintain quality standards.

• Offer guidance, oversight, and feedback to the CRA team concerning project scope, SOPs, timelines, and budgets.

• Review monitoring visit reports and perform co-monitoring and evaluation visits.

• Ensure timely and appropriate investigator site visits.

• Coordinate with cross-functional departments to address clinical trial monitoring challenges.

• Assist in the development of study-specific Monitoring Plans and training presentations.

• Help with ethics documentation and site contract negotiations.

• Provide monthly billing details to the finance team.

• Manage study budgets and serve as the sponsor referent for stand-alone projects.

• Conduct qualification, initiation, interim, and close-out visits both remotely and on-site.

• Prepare precise monitoring visit reports that document site issues, resolutions, actions taken, protocol deviations, study progress, and enrollment metrics.

• Ensure the integrity of CRF data through source document review and verification.

• Perform quality control and verification of site documents for eTMF/TMF.

• Manage investigational product accountability.

• Review regulatory binders from study sites.

• Maintain communication with study sites to ensure compliance with protocols/GCP and to assess patient accrual.

• Ensure compliance with ICH GCP, FDA regulations, and company/Sponsor SOPs.

• Participate in internal, client/sponsor, scientific, and other relevant meetings.

• Facilitate adverse event reporting and reconcile SAE reports with source documents and CRFs.

• Resolve data discrepancies in collaboration with in-house CRAs/CTC and data management.

• Identify site issues and devise problem-solving strategies.

• Prepare for audits at study sites.

• Collaborate with other CRAs.

• Assist in the training and onboarding of new CRAs.

• Mentor CRAs.

• Contribute to the development and maintenance of the CTMS.

• Manage competing priorities and fulfill commitments.

• Perform additional assigned responsibilities.

⛳️ Requirements

• At least 3 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO sector, with the ability to independently manage monitoring tasks.

• Experience in the Oncology field.

• Willingness to travel as needed.

• Quality-focused with a proven track record of being meticulous, thorough, and detail-oriented.

• Strong organizational abilities and the capacity to multitask effectively in a dynamic environment.

• Competence in prioritizing tasks, managing time, and solving problems.

• Excellent analytical, negotiation, meeting management, cross-functional team collaboration, and leadership skills.

• Ability to travel as required.

• Capability to manage stress effectively.

• Professional, trustworthy, and disciplined demeanor.

• Proficient in problem-solving unstructured or ambiguous challenges.

• Strong command of the local language, both written and verbal, in the region where monitoring activities are conducted.

• Excellent communication and interpersonal skills with a customer service focus.

• Proficient computer skills, including the use of clinical trial management systems, clinical trial databases, and electronic data capture.

• Self-motivated individual who excels in a collaborative, yet less structured team setting.

• Knowledge of clinical research, ICH GCP, and local regulations.

• Familiarity with regulatory and ethical requirements.

• Ability to build and maintain positive relationships with Sponsors, Site, and Project Team members.

• EU: Degree in a scientific health field.

• EU: Proficient in English.

• Bachelor of Science (BS) in Biology, Biotechnology, Life Sciences, or Pharmacy.

🏝️ Benefits

• Comprehensive health insurance options.

• Opportunities for professional development and training.

• Flexible work arrangements.

• Competitive salary and performance-based bonuses.

• Supportive work culture focused on collaboration and teamwork.