Clinical Research Coordinator

hace 1 semana

Xico, México Novasyte A tiempo completo
Job Overview

Novasyte is seeking a highly skilled Clinical Research Coordinator to join our team. As a Clinical Research Coordinator, you will be responsible for performing monitoring and site management work for a variety of protocols, site and therapeutic areas.

Key Responsibilities:
  • Perform site monitoring visits (selection, initiation, monitoring and close-out 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.
Qualifications:
  • Bachelor's Degree in a scientific discipline or healthcare preferred.
  • Requires at least 3 years of on-site monitoring experience.
  • Equivalent combination of education, training and experience may be accepted in lieu of degree.
  • 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.

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