Clinical Research Associate

hace 1 mes

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

The Clinical Research Associate will be responsible for ensuring the compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

Key Responsibilities:

  • Develop and maintain strong site relationships and ensure continuity of site relationships throughout all phases of the trial.
  • Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
  • Gain an in-depth understanding of the study protocol and related procedures.
  • Coordinate and manage various tasks in collaboration with other sponsor roles to achieve Site Ready.
  • Participate and provide inputs on site selection and validation activities.
  • Perform remote and on-site monitoring and oversight activities using various tools to ensure data generated at site are complete, accurate, and unbiased.
  • Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive, and accurate visit and non-visit contact reports appropriately in a timely manner.
  • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.
  • 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.
  • 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.
  • 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.
  • Manage and maintain information and documentation in CTMS, eTMF, and various other systems as appropriate and per timelines.
  • Contribute to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor, and sharing best practices as appropriate/required.
  • Support and/or lead audit/inspection activities as needed.
  • Perform co-monitoring visits where appropriate.
  • Following the country strategy defined by CRD and/or CRA manager, contribute to the identification of new potential sites and work closely with them to develop strong clinical research capabilities.

Key Competencies:

  • 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.

Behavioural Competency Expectations:

  • Effective time management, organizational and interpersonal skills, conflict management, problem-solving skills.
  • 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.

Requirements:

  • Required: Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
  • Preferred: B.A./B.S. with strong emphasis in science and/or biology.

Employee Status: Project Temps (Fixed Term)

Travel Requirements: Flexible Work Arrangements: Hybrid

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