Senior Clinical Research Associate

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

📋 Description

• Independently carry out site monitoring duties for clinical trials.

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

• Ensure adherence to protocols, quality standards, SOPs, timelines, and budget constraints.

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

• Guarantee 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 documentation, and site contract negotiations.

• Supply monthly billing information 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 that outline site issues, resolutions, protocol deviations, study progress, and enrollment status.

• Verify source documents to ensure the integrity of CRF data.

• Perform quality control and verification of eTMF/TMF documentation.

• Manage investigational product accountability and review site regulatory binders.

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

• Ensure compliance with ICH GCP guidelines, FDA regulations, and organizational/sponsor SOPs.

• 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 teams.

• Identify site-related issues and develop effective problem-solving strategies.

• Prepare study sites for audits.

• Mentor CRAs and assist in CRA onboarding and training processes.

• Collaborate on the development and upkeep of the Clinical Trial Management System (CTMS).

• Manage competing priorities and undertake additional assigned responsibilities.

⛳️ Requirements

• At least 3 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO sectors.

• Capability to manage monitoring activities independently.

• Willingness to travel throughout Romania.

• Experience in oncology.

• Proficiency in Romanian and English; knowledge of additional languages is an advantage.

• Strong grasp of the local language, both written and spoken, in the country where monitoring activities take place.

• Degree in a scientific health-related field.

• Sufficient English language skills.

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

• Excellent organizational skills and the ability to multitask in a dynamic environment.

• Competence in managing priorities, organizing time, and problem-solving.

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

• Willingness to travel and manage stress effectively.

• Professional, reliable, and disciplined demeanor.

• Capability to address unstructured or ambiguous challenges.

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

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

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

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

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

🏝️ Benefits

• Opportunity for remote work.

• Flexible part-time schedule.

• Engagement in freelance/contingency workforce roles.