Medical Device Clinical Research Specialist

Há 2 dias

Belém, Pará, Brasil beBeeClinical Tempo inteiro US$70.000 - US$95.000
About the Role

We are seeking an experienced Clinical Research Coordinator to join our team. As a key member of our clinical affairs team, you will play a vital role in ensuring the successful execution of clinical registries and post-market surveillance activities.

Key Responsibilities
  • Assist in the planning and implementation of clinical research protocols.
  • Coordinate with clinical sites to facilitate subject recruitment, retention strategies, and support overall study enrollment goals.
  • Support day-to-day operations of assigned studies, ensuring adherence to protocol requirements and timelines.
  • Act as a contact for site staff and ensure clear communication regarding study updates.
  • Manage electronic data capture systems and provide training to site staff.
Data Management
  • Maintain and oversee study documentation, including source documents and regulatory files.
  • Ensure accurate data collection, entry, and quality control, perform data analysis, and collaborate with the study management team to resolve discrepancies.
  • Conduct regular site reviews of clinical data and inform the study management team of items requiring resolution.
Regulatory Compliance
  • Evaluate study-related activities to ensure compliance with federal, state, and local regulations, ICH-GCP guidelines, ISO 14155, applicable FDA, ISO 13485, and MDR regulations.
  • Assist with Institutional Review Board (IRB) and Ethics Committee submissions, including protocol amendments, adverse event reporting, and study renewals.
Qualifications
  • Bachelor's degree in life sciences, healthcare, or a related field.
  • 1-2 years of experience in clinical research/clinical affairs, within the medical device industry.
  • Familiarity with Electronic Data Capture (EDC) systems and clinical trial management software.
  • Excellent organizational skills, attention to detail, and ability to prioritize tasks effectively.

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