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Clinical Research Associate III

2 meses atrás

São Paulo, São Paulo, Brasil MSD Tempo inteiro
Job Title: Clinical Research Associate

Merck & Co., Inc. is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for ensuring the successful execution of clinical trials in a country.

Responsibilities:
  • Accountable for performance and compliance for assigned protocols and sites in a country.
  • Ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards, and adverse event reporting requirements.
  • Serves as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
  • Develops and expands the territory for clinical research, finding and developing new sites.
  • Participates in internal meetings and workstreams as SME for monitoring processes and systems.
  • Performs Quality control visits if delegated by other roles and trained appropriately.
Required Competencies:
  • Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
  • Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
  • Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
  • Demonstrated ability to mentor/lead.
  • Hands on knowledge of Good Documentation Practices.
  • Proven Skills in Site Management including independent 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, also in a virtual environment.
  • Experience with conducting site motivational visit designed to boost site enrollment.
  • Capable of managing complex issues, works in a solution-oriented manner.
  • Performs root cause analysis and implements preventative and corrective action.
  • Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate.
Behavioral 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 and 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.
Experience Requirements:
  • Must have direct experience of site management (monitoring) experience in a bio/pharma/CRO.
Educational Requirements:
  • B.A./B.S. with strong emphasis in science and/or biology.
Important Details:
  • The candidate must be either from São Paulo (Capital) or neighbor cities OR from the South region of Brazil.
  • This role is expected to travel (75% of time).
  • The candidate is expected to travel on day to day basis to complete the requested activities with clients and Clinical Centers.