Clinical Research Associate

hace 8 horas

Bogotá, Bogotá D.E., Colombia MSD A tiempo completo
Job Description

The Clinical Research Associate (CRA) is accountable for ensuring the performance and compliance of assigned protocols and sites in a country. Under the oversight of the CRA manager, the CRA ensures compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

Key Responsibilities:

  1. Develop and maintain strong site relationships and ensure continuity of site relationships throughout all phases of the trial.
  2. Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
  3. Gain an in-depth understanding of the study protocol and related procedures.
  4. Coordinate and manage various tasks in collaboration with other sponsor roles to achieve Site Ready.
  5. Participate and provide inputs on site selection and validation activities.
  6. Perform remote and on-site monitoring and oversight activities using various tools to ensure data generated at site are complete, accurate, and unbiased, and subjects' rights, safety, and well-being are protected.
  7. Conduct site visits, including validation visits, initiation visits, monitoring visits, close-out visits, and record clear, comprehensive, and accurate visit and non-visit contact reports in a timely manner.
  8. Collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.
  9. Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
  10. Identify, assess, and resolve site performance, quality, or compliance problems and escalate per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head, and CRD as needed.
  11. Work in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, and regional operations, HQ functional areas, and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
  12. Manage and maintain information and documentation in CTMS, eTMF, and various other systems as appropriate and per timelines.
  13. Contribute to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor, and sharing best practices as appropriate/required.
  14. Support and/or lead audit/inspection activities as needed.
  15. Perform co-monitoring visits where appropriate.
  16. Contribute to the identification of new potential sites and work closely with them to develop strong clinical research capabilities.

Requirements:

  • Minimum 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
  • Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
  • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
  • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
  • Hands-on knowledge of Good Documentation Practices.
  • Proven skills in site management, including management of site performance and patient recruitment.
  • Demonstrated high level of monitoring skill with independent professional judgment.
  • Good IT skills (use of MS office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices.
  • Ability to understand and analyze data/metrics and act appropriately.
  • Capable of managing complex issues, works in a solution-oriented manner.
  • Performs root cause analysis and implements preventative and corrective action.

Behavioural Competency Expectations:

  • Effective time management, organizational, and interpersonal skills, conflict management, problem-solving skills.
  • Demonstrated high level of monitoring skill with independent professional judgment.
  • Able to work highly independently across multiple protocols, sites, and therapy areas.
  • High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
  • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
  • Demonstrates commitment to Customer focus.
  • Works with high quality and compliance mind-set.
  • Positive mindset, growth mindset, capable of working independently and being self-driven.
  • Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

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