Senior Clinical Research Associate

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

📋 Description

• Independently perform site monitoring duties for clinical trials.

• Provide leadership, oversight, and guidance to CRA teams.

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

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

• Coordinate investigator site visits and address clinical trial monitoring challenges.

• Assist with the development of monitoring plans, training presentations, ethics documents, and site contract negotiations.

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

• Carry out qualification, initiation, interim, and closeout visits both remotely and onsite.

• Prepare timely and accurate monitoring visit reports.

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

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

• Conduct investigational product accountability and review site regulatory binders.

• Maintain continuous communication with study sites, assess patient accrual, and respond to sponsor requests.

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

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

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

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

• Prepare for audits at study sites.

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

• Assist with CRA training, mentor CRAs, and collaborate on the development and maintenance of CTMS.

• Manage conflicting priorities and perform additional assigned responsibilities.

⛳️ 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 Italy.

• Oncology experience is mandatory.

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

• Competency in English.

• Certified Monitor as per the Italian CRO decree dated 15Nov2011.

• Degree in a scientific health field.

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

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

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

• Ability to multitask, manage priorities, organize time effectively, solve problems, handle stress, and navigate ambiguous challenges.

• Professional, trustworthy, and disciplined demeanor.

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

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

• Knowledgeable in clinical research, ICH GCP, local regulations, and regulatory and ethical requirements.

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

🏝️ Benefits

• A global, collaborative team environment.

• Opportunities for leadership, mentoring, and professional growth through CRA new-hire training and onboarding.

• Flexible remote and onsite work arrangements for clinical trial visits.