Clinical Research Associate II

Há 4 dias

São Paulo, São Paulo, Brasil Caidya Tempo inteiro
Job Title: Clinical Research Associate II

Job Summary: We are seeking a highly skilled Clinical Research Associate II to join our team at Caidya. As a Clinical Research Associate II, you will be responsible for monitoring investigational sites to ensure subject safety and providing high-quality data review and reporting in compliance with regulatory requirements.

Key Responsibilities:

  • Monitor investigational sites to ensure subject safety and compliance with regulatory requirements.
  • Provide high-quality data review and reporting in compliance with regulatory requirements.
  • Build and manage site relationships while serving as liaison between the Sponsor and assigned sites.
  • Verify that the investigator, staff, and site facilities remain adequate throughout the trial period.
  • Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits, and close-out visits according to the Monitoring Plan.
  • Ensure assigned sites are conducting studies according to protocol requirements or investigational plan and applicable regulations and guidelines.
  • Verify that the rights and well-being of trial subjects are protected.
  • Reconcile site regulatory binder assuring collection and completeness of regulatory documents.
  • Collect and ensure completeness of all essential regulatory documentation from sites from study start-up through close-out.
  • May support translations of essential documents.
  • May support submission of trials to IRB/IEC and regulatory authorities.
  • Verify that written informed consent was obtained before each subject's participation in the trial.
  • Verify that the investigator is enrolling only eligible subjects.
  • Perform source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan.
  • Ensure accurate and complete data and that corrections are appropriately documented by authorized site staff.
  • Verify the quality of all recorded data.
  • Issue and ensure timely resolution of all data queries remotely or at investigator site.
  • Perform Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
  • Verify and support the recording and reporting of adverse events/serious adverse events.
  • Ensure that sites have sufficient project-specific supplies.
  • Manage investigative sites in respect to the trial conduct and motivate sites to meet study goals.
  • Communicate deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and take appropriate action to prevent recurrence.
  • Deliver quality written trip reports, confirmation, and follow-up letters within timelines of SOPs and Monitoring Plans.
  • Attend and participate in team teleconferences and training.
  • Participate in relevant trial meetings, e.g., Kick off, Investigator, and Monitor meetings.
  • Participate in site audits, as requested.
  • May conduct site and study feasibility assessments.
  • May be involved in the development of monitoring guidelines and tools.
  • Provide input into study documentation and monitoring worksheets.
  • Uphold the confidentiality agreements with all clients and colleagues outside Caidya.
  • Pays attention to signals of fraud, misconduct, and escalates per Caidya SOP.
  • Work according to the Caidya Quality Management System and actively participate in giving feedback and suggesting improvements to current processes.
  • Work according to the project-specific timelines and budget agreement, which has been agreed upon with the sponsor.
  • Accurately document the time spent per project in the Caidya time allocation system.
  • Demonstrate flexibility and adaptability.
  • Proactively identify, manage, escalate (as needed), and resolve site issues effectively and independently.
  • Other duties as assigned by Clinical Operations Manager/Project Manager and per project-specific requirements.
  • May participate in delivering Clinical Monitoring portion of a bid defense presentation.

Requirements:

  • Education: 4-year college graduate, preferably with a healthcare or life science degree.
  • Experience: Minimum of 1 year of experience in on-site monitoring clinical studies.
  • Skills/Competencies: Strong written and verbal communication skills, strong interpersonal skills, strong monitoring skills to independently conduct all types of site monitoring visits, good documentation skills, good command of English and the local language in the area of activity (reading, writing, understanding), proficient computer skills, including Microsoft Office, comprehensive knowledge of GCP/ICH guidelines, proficiency in medical terminology, able to exercise judgment within defined procedures and practices and to determine appropriate action independently, attention to detail, problem-solving skills, ability to work in a matrix environment, strong time management and organizational skills.
  • Capabilities: Ability to drive an automobile and have a valid driver's license, if applicable, valid passport required in the case of international business travel, ability to travel up to 80%.

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