Senior Clinical Research Associate

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

📋 Description

• Independently perform site monitoring responsibilities for clinical trials.

• Offer oversight, leadership, and direction in the management and execution of clinical trials.

• Mentor, guide, and provide feedback to CRA team members.

• Examine 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 development of monitoring plans, training presentations, ethics documents, and site contract negotiations.

• Supply monthly billing information and manage study budgets for standalone projects.

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

• Create precise monitoring visit reports documenting site issues, resolutions, protocol deviations, study progress, and enrollment metrics.

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

• Conduct quality control and verification of eTMF/TMF documents.

• Manage investigational product accountability and review site regulatory binders.

• Maintain communication with study sites to ensure compliance with protocols and GCP.

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

• Address data discrepancies in collaboration with in-house CRAs, CTC, and data management.

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

• Prepare study sites for audits.

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

• Support CRA training and onboarding; mentor CRAs.

• Collaborate in the development and upkeep of the CTMS.

• Handle conflicting priorities and perform additional assigned tasks.

⛳️ Requirements

• At least 4 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO sectors.

• Capability to independently manage monitoring activities.

• Willingness to travel within Spain.

• Experience in oncology is essential.

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

• Adequate command of English.

• Degree in a scientific health field.

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

• Quality-focused, meticulous, thorough, and detail-oriented.

• Strong organizational skills with the ability to multitask in a fast-paced environment.

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

• Excellent analytical, negotiation, meeting management, cross-functional teamwork, and leadership abilities.

• Capacity to manage stress and tackle unstructured or ambiguous challenges.

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

• Good computer proficiency, including familiarity with clinical trial management systems, clinical trial databases, and electronic data capture.

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

• Ability to establish and maintain positive relationships with sponsors, sites, and project team members.

🏝️ Benefits

• Flexible remote work arrangement.

• Opportunities for collaboration across global teams and various time zones.

• Regular travel within Spain.

• Professional development through CRA new hire training, onboarding, and mentorship.