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Clinical Research Associate

4 mesi fa

Roma, Lazio, Italia MSD A tempo pieno
The Clinical Research Associate Role

The role of Clinical Research Associate involves overseeing the performance and compliance of assigned protocols and sites in a country. Under the guidance of the CRA manager, the individual ensures study conduct compliance with ICH/GCP, country regulations, Company policies, quality standards, and adverse event reporting requirements both internally and externally. Acting as the primary site contact and manager throughout all phases of a clinical research study, the CRA takes overall responsibility for allocated sites. Besides, actively expanding the territory for clinical research by seeking and fostering new sites. Additionally, the CRA participates in internal meetings as a Subject Matter Expert (SME) for monitoring processes and systems.

Responsibilities include, but are not limited to:
  • Performing clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
  • Conducting site visits, such as validation visits, initiation visits, monitoring visits, and close-out visits, and documenting visit & non-visit contact reports accurately and promptly.
  • Collecting, reviewing, and monitoring required regulatory documentation for study start-up, maintenance, and close-out.
  • Engaging with Investigators and site staff on protocol-related issues, recruitment, retention, deviations, audits/inspections, and overall site performance.
  • Identifying, assessing, and resolving site performance, quality, or compliance problems and escalating per defined CRA Escalation Pathway in collaboration with relevant stakeholders.
  • Collaborating with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas, vendors, IRB/IECs, and Regulatory Authorities to support assigned sites.
  • Supporting and/or leading audit/inspection activities as necessary.
Experience Requirements:

Minimum of 3 years of direct site management (monitoring) experience in a bio/pharma/CRO company.

Educational Requirements:

Bachelor's degree with a strong focus on science and/or biology.

CORE Competency Expectations:
  • Proficiency in Local Languages and English (verbal and written) with strong communication skills.
  • Thorough understanding and practical knowledge of clinical research, clinical trial phases, GCP/ICH standards, and local clinical research laws.
  • Familiarity with Global, Country/Regional Clinical Research Guidelines and ability to operate within these guidelines.
  • Hands-on experience with Good Documentation Practices.
  • Demonstrated skills in Site Management, including performance management and patient recruitment.
  • High level of monitoring skills with independent professional judgment.
  • Good IT skills (MS Office, various clinical IT applications, adaptability to new IT applications).
  • Ability to analyze data/metrics and take appropriate actions.
  • Proficient in managing complex issues in a solution-oriented approach.
  • Conducting root cause analysis and implementing preventive and corrective measures.
Behavioral Competency Expectations:
  • Effective time management, organizational and interpersonal skills, conflict resolution, and problem-solving abilities.
  • Capability to work independently across multiple protocols, sites, and therapeutic areas.
  • Strong sense of accountability and ability to prioritize tasks in a dynamic environment.
  • Effective collaboration in a multicultural setting, maintaining culturally sensitive working relationships.
  • Dedication to Customer focus and a positive, growth-oriented mindset, self-driven and independent.

We value diversity and inclusion, believing that breakthrough innovation arises when diverse ideas converge in an inclusive atmosphere. We encourage respectful challenges among colleagues and a collective problem-solving approach. As an equal opportunity employer, we are committed to creating an inclusive and diverse workplace.