Senior Clinical Research Professional

Há 24 horas

São Paulo, São Paulo, Brasil beBeeClinicalResearch Tempo inteiro
Job Description

As a Senior Clinical Research Associate, you will be responsible for managing site responsibilities for clinical studies according to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and applicable project plans.

  • Verify study training records and ensure compliance with SOPs, GCP, and regulatory requirements.
  • Conduct site monitoring responsibilities for clinical trials, including pre-study, site initiation, process monitoring, routine monitoring, and close-out visits.
  • Prepare and implement project plans related to Clinical Monitoring responsibilities.
  • Ensure the protection of subjects by verifying informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
  • Safeguard data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
Required Skills and Qualifications

Thorough understanding of ICH GCP Guidelines and knowledge of local regulatory requirements is essential. Experience in clinical research operations, preferably as a CRA or Lead CRA, is also necessary.

  • University degree or certification in a related field (e.g., nursing licensure).
  • Strong communication and interpersonal skills.
  • Ability to work independently with minimal supervision.
  • Good analytical and problem-solving skills.
  • Fluent English and intermediate/advanced Spanish language proficiency.
Benefits

As a Senior Clinical Research Associate, you will enjoy a competitive salary package, comprehensive benefits, and opportunities for professional growth and development.

  • Full-time employment with flexible working hours.
  • Opportunities for career advancement and professional development.
  • Comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • Collaborative and dynamic work environment.
Others

Fortrea offers a range of benefits and perks to support your overall well-being and quality of life.

  • Flexible working hours and remote work options.
  • Access to employee assistance programs and mental health resources.
  • On-site fitness center and wellness initiatives.
  • Professional development opportunities and training programs.

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