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MSD Clinical Research Associate III São Paulo - Capital & Sul 
Brazil, São Paulo 
854349919

01.09.2024

Job Description

Responsibilities:

  • The role is accountable for performance and compliance for assigned protocols and sites in a country.

  • Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.

  • Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

  • Actively 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.

  • Could perform 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 analyses 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 / 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.

Experience Requirements:
Required
:

  • Must have direct experience of site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements:
Preferred:

  • 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.

Current Contingent Workers apply


Not Applicable1st - Day

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.



Job Posting End Date:09/07/2024


A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.