CRA
QuintilesIMS
Sao Paulo, Brazil
há 5 horas

RESPONSIBILITIES

  • Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
  • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
  • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
  • 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.

  • 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.

  • Build awareness of features and opportunities of study to site.
  • Collaborate and liaise with study team members for project execution support as appropriate. All responsibilities are essential to job functions unless noted as non-essential .
  • REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Good 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
  • Strong written and verbal communication skills including good command of English language
  • Strong organizational and problem-solving skills
  • Effective time management skills
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor's degree in a health care or other scientific discipline or educational on-site monitoring experience; or equivalent combination of education, training and experience
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