Clinical Research Associate II

Há 1 mês

São Paulo, São Paulo, Brasil MSD Tempo inteiro

Job Description

Responsibilities include, but are not limited to:

  • The role is responsible for performance and compliance for assigned protocols and sites in a country;
  • Ensures study conduct compliance with ICH/GCP and country regulations, company policies, quality standards, and adverse event reporting requirements;
  • Acts as primary site contact and manager throughout all phases of a clinical research study;
  • Develops and expands territory for clinical research, finding and nurturing new sites;
  • Participates in internal meetings as a Subject Matter Expert for monitoring processes;
  • Builds strong site relationships and ensures continuity through all study phases;
  • Performs site management/monitoring activities in adherence to guidelines;
  • Gains a deep understanding of study protocols and related procedures;
  • Manages tasks in collaboration with other roles to achieve Site Ready;
  • Participates in site selection and validation activities;

Performs remote and on-site monitoring and oversight activities to ensure:

  • Data accuracy and completeness at sites;
  • Protection of subjects' well-being and rights;
  • Conducts various site visits and records clear reports in a timely manner;
  • Reviews and monitors required regulatory documentation;
  • Communicates with Investigators and site staff on protocol-related issues;
  • Resolves site performance and compliance problems;
  • Collaborates with various internal and external stakeholders;
  • Manages information in various systems;
  • Acts as a Subject Matter Expert and mentor;
  • Supports audit activities;
  • Contributes to the identification of new potential sites according to country strategy.

Requirements:

  • Bachelor's degree required, with emphasis in life sciences or related field;
  • Fluency in Portuguese and advanced proficiency in English required;
  • Prior experience in clinical research;
  • Direct site management experience in a bio/pharma/CRO setting required.

CORE Competency Expectations:

  • Understanding of clinical research, GCP/ICH, and country regulations;
  • Knowledge of Global and Regional Clinical Research Guidelines;
  • Good Documentation Practices;
  • Skills in Site Management and patient recruitment;
  • High level of monitoring skill with professional judgment;
  • IT proficiency and adaptability to new applications;
  • Ability to analyze data and problem-solve;
  • Capability to manage complex issues and implement actions;

Behavioural Competency Expectations:

  • Effective time management, organizational, and interpersonal skills;
  • Collaborative mindset for skill development across various areas;
  • Accountability and ability to set priorities;
  • Ability to work in a multicultural environment;
  • Demonstrates commitment to Customer focus;
  • Professional demeanor and communication;

Important details:

  • Candidates preferably from certain regions in Brazil;
  • Remote work supported, with extensive travel required;
  • Expected travel for daily activities with clients and Clinical Centers;
  • Open to candidates legally permitted to work in Brazil from any nationality.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

75%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

No

Job Posting End Date:

05/23/2024

*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.

Requisition ID:

R291421

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