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Monitoring Operations Specialist

hace 2 semanas


San José, San José, Costa Rica Novasyte A tiempo completo

Job Description

We are seeking a skilled Monitoring Operations Specialist to join our team at Novasyte. In this role, you will be responsible for performing monitoring and site management work for a variety of protocols, including therapeutic areas.

Key Responsibilities:

  • Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • Escalate quality issues as appropriate.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
  • May support start-up phase.
  • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  • Act as a mentor for clinical staff including conducting co-monitoring and training visits.
  • Collaborate and liaise with study team members for project execution support as appropriate.
  • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Requirements:

  • Bachelor's Degree in a scientific discipline or healthcare preferred.
  • Requires at least 6 years of on-site monitoring experience.
  • In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Strong therapeutic and protocol knowledge as provided in company training.
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
  • Written and verbal communication skills including good command of English language.
  • Organizational and problem-solving skills.
  • Effective time and financial management skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.