Clinical Research Associate II

Accountabilities

• • Perform and coordinate assigned clinical monitoring activities in accordance with ICH-GCP guidelines, applicable regulations, and internal SOPs.
  • Conduct site visits, including pre-study site visits, site initiation visits, interim monitoring visits, and close-out visits.
  • Act as the primary site manager, maintaining effective communication and collaborative relationships with investigators and key site personnel.
  • Assess protocol compliance, regulatory adherence, patient safety, and data quality during monitoring activities.
  • Prepare accurate and timely monitoring reports and other required clinical documentation.
  • Provide protocol, study, and related training to assigned clinical research sites and support project-specific training for study teams.
  • Monitor site performance by tracking enrollment, Case Report Form (CRF) data entry, protocol deviations, and other site-level metrics.
  • Communicate site performance, risks, issues, and trends to the Clinical Study Team.
  • Perform Serious Adverse Event (SAE) reconciliation and collaborate with sites to resolve discrepancies.
  • Work with clinical study teams and investigative sites to ensure timely achievement of study milestones, including study start-up, recruitment, database activities, and close-out.
  • Support regional investigator meetings and site booster visits when required.
  • Assist clinical sites with audit and inspection preparation and ensure identified quality issues or findings are appropriately addressed through resolution.
  • Mentor and support less experienced CRAs on general and study-specific monitoring topics.
  • Participate in co-monitoring activities and provide additional support during site visits when needed.
  • Undertake other clinical responsibilities within the scope of the role as assigned.

  Requirements

  • Bachelor’s degree in a relevant scientific discipline or equivalent academic background.
  • At least 2 years of relevant clinical operations experience, including a minimum of 1 year of clinical monitoring experience.
  • Experience with global clinical trials is preferred, particularly within oncology or hematology.
  • Pharmaceutical or biotechnology industry experience is highly desirable.
  • Thorough understanding of clinical trial processes, ICH-GCP principles, and applicable regulatory requirements.
  • Experience conducting site monitoring visits and managing investigative sites.
  • Strong understanding of protocol compliance, data quality, patient safety, and clinical documentation requirements.
  • Excellent written and verbal communication skills in English; fluency is required. Spanish is considered a plus.
  • Strong interpersonal and relationship-building skills for effective collaboration with investigators, vendors, study teams, and other stakeholders.
  • Excellent organizational and prioritization skills, with the ability to manage multiple activities and deadlines simultaneously.
  • Ability to work independently while contributing effectively to a global, cross-functional team.
  • Strong analytical, problem-solving, and attention-to-detail capabilities.
  • Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
  • Familiarity with clinical trial management systems (CTMS) and clinical data management systems.
  • Ability and willingness to travel extensively, with up to 70% travel required.

  Benefits

  • Full-time, remote position based in Brazil.
  • Opportunity to work on clinical trials with global scope.
  • Exposure to pharmaceutical and biotechnology clinical research, with a focus on areas such as oncology and hematology.
  • Opportunity to take ownership of site management and clinical monitoring activities.
  • Mentoring and development opportunities through collaboration with experienced clinical research professionals.
  • Opportunity to support and mentor less experienced CRAs.
  • Collaborative, cross-functional, and internationally oriented working environment.
  • Professional development through disease-area, project-specific, and study-related training.
  • Meaningful opportunity to contribute to clinical research and the development of innovative treatments.