Site Management Specialist

1 semana atrás

São Paulo, São Paulo, Brasil beBeeClinicalResearchAssociate Tempo inteiro R$800.000 - R$1.000.000
Job Overview

Clinical Research Associate I with at least 1 year of site management experience - dedicated to delivering exceptional results.

Responsibilities:
  • Deliver high-quality site qualification, initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory compliance. Utilize judgment and experience to evaluate site performance and provide recommendations for improvement.
  • Verify informed consent processes and maintain confidentiality of subject data. Assess factors affecting site safety and clinical data integrity.
  • Conduct Source Document Review and verify required clinical data entered in the case report form is accurate and complete.
  • Apply query resolution techniques remotely and on-site, providing guidance to site staff as needed.
  • Collaborate with Sponsor affiliates, medical science liaisons, and local country staff to drive project success.
  • Perform investigational product inventory, reconciliation, and reviews storage and security.
  • Reconcile Investigator Site File contents with the Trial Master File and ensure adherence to local regulations.
  • Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
  • Support subject recruitment, retention, and awareness strategies.
Qualifications:
  • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
  • Minimum 1 year prior clinical research or monitoring experience.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Strong analytical and problem-solving skills.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage travel of up to 75% on a regular basis.
Skills and Certifications:
  • Attention to detail and strong analytical skills.
  • Problem-solving abilities and critical thinking.
  • Proficiency in Microsoft Office Suite.
Benefits:

Syneos Health offers a dynamic work environment, opportunities for professional growth, and a commitment to our Total Self culture – where you can authentically be yourself.

Discover what our employees already know: WORK HERE MATTERS EVERYWHERE.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

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