Clinical Trial Site Coordinator

Há 6 dias

Vitória, Espírito Santo, Brasil beBeeSiteActivation Tempo inteiro US$70.000 - US$100.000
Site Activation Professional

Parexel FSP is currently seeking skilled professionals to fill multiple Site Activation Partner positions in Brazil.

Key Responsibilities:
  • The selected candidate will be responsible for initiating and coordinating site activation activities, ensuring the compilation of high-quality documents and compliance with regulatory requirements.
  • This involves registering investigator sites and client stakeholders in relevant registries and systems, maintaining accurate records, and being inspection-ready.
  • The professional will work directly with investigator sites to confirm readiness for site start-up, reviewing study site profiles, completing critical information sheets, and managing essential documents.
  • They will also take the lead in resolving issues or concerns, escalating site-related matters when necessary.
  • Ongoing tasks include preparing, validating, and submitting regulatory documents, such as completed Investigator Initiation Packages (IIP), IRB approval forms, and FDA 1572/Attestation Forms, within required timelines.
  • This role requires effective communication and coordination with other supporting roles to ensure timely site activation and operational activities.
Required Skills and Qualifications:
  • A minimum of 2 years' experience in clinical site management is required.
  • Prior experience working in the pharmaceutical industry or CRO in study site activation is preferred.
  • Candidates must possess knowledge of clinical trial methodologies, ICH/GCP, FDA regulations, and global/local country regulations.
  • Strong technical skills and ability to learn and use multiple systems are essential.
  • Demonstrated knowledge of clinical research and development processes, key operational elements of a clinical trial, and ability to gain command of process details.
  • Candidates should understand quality expectations, emphasis on right first-time delivery, and comply with all applicable company, regulatory, and country requirements.
  • Able to work independently and as part of a team, with excellent organizational, time management, and prioritization skills.
Benefits:
  • Fluency in local language and English is mandatory; multilingual capability is an asset.
  • A good understanding of the site activation requirements and processes within the country/region and ability to adapt to new environments.
Additional Information:
  • May be assigned as a Site Activation Partner Point of Contact (PoC) on multi-country studies.
  • May serve as a Subject Matter Expert (SME) on systems and processes, representing the SAP function as needed.
  • Able to act as an SME on projects and initiatives, as requested.

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