Senior Clinical Research Associate

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

📋 Description

• Independently conduct site monitoring duties for clinical trials.

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

• Ensure adherence to protocols and maintain high-quality standards.

• Offer guidance, oversight, and feedback to the CRA team concerning project scope, standard operating procedures (SOPs), timelines, and budgets.

• Review monitoring visit reports and carry out co-monitoring and evaluation visits.

• Ensure timely visits to investigator sites.

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

• Assist in the creation of Monitoring Plans and training presentations.

• Support the preparation of ethics documents and the negotiation of site contracts.

• Provide monthly billing data to the finance department.

• Manage study budgets and serve as the sponsor referent for independent projects.

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

• Prepare detailed monitoring visit reports documenting site issues, resolutions, protocol deviations, study progress, and enrollment statistics.

• Review source documents and ensure the integrity of CRF data.

• Execute quality control and document verification for electronic Trial Master Files (eTMF/TMF).

• Oversee investigational product accountability.

• Review site regulatory binders.

• Maintain ongoing communication with study sites regarding protocol/GCP compliance, patient recruitment, and sponsor requests.

• 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 Serious Adverse Event (SAE) reports with source documentation and CRFs.

• Address data discrepancies with CRAs/CTC and data management teams.

• Identify site-related issues and formulate problem-solving strategies.

• Prepare for audits at study sites.

• Assist in the training and onboarding of CRAs.

• Mentor CRAs in their professional development.

• Collaborate on the development and maintenance of Clinical Trial Management Systems (CTMS).

• Effectively manage competing priorities and fulfill commitments.

• Perform additional assigned responsibilities.

⛳️ Requirements

• A minimum of 3 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry, with the ability to manage monitoring activities independently.

• Experience in oncology.

• Willingness to travel as required.

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

• Strong organizational capabilities and the ability to multi-task effectively in a fast-paced environment.

• Proficient in managing priorities, organizing time, and solving problems.

• Strong analytical, negotiation, meeting management, cross-functional teamwork, and leadership skills.

• Ability to manage travel commitments.

• Capacity to handle stress effectively.

• Professional demeanor, trustworthy, and disciplined.

• Competence in addressing 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 orientation.

• Proficient computer skills, including experience with clinical trial management systems, clinical trial databases, and electronic data capture.

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

• Knowledgeable about clinical research, ICH GCP, and local regulations.

• Familiarity with regulatory and ethical requirements.

• Ability to forge and maintain positive relationships with sponsors, site personnel, and project team members.

• Graduation in a scientific health-related field.

• Proficient in English.

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

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health insurance and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible working hours and potential remote work options.

• Supportive and collaborative team environment.