Senior Clinical Research Associate

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Conduct feasibility assessments for potential sites.

• Carry out pre-study activities, initiate studies, monitor interim progress, manage sites, and complete study close-out visits.

• Serve as the Lead CRA for international studies and oversee CRAs.

• Create Clinical Monitoring Plans.

• Evaluate site visit trip reports, providing constructive feedback and necessary edits.

• Mentor and support less experienced CRAs and site personnel.

• Develop study-specific tools and templates.

• Engage in study team, investigator, and bid defense meetings.

• Design and deliver training sessions for study team members or colleagues.

• Collaborate with Project Management to assess deliverables and study milestones.

• Compile necessary regulatory and ethical submission documentation.

• Coordinate the shipment and receipt of study materials.

• Document findings from site visits in written reports.

• Contribute to protocol and CRF design.

• Evaluate, monitor, and train site staff on adherence to protocols.

• Review subject safety information and informed consent forms.

• Conduct verification of source documents.

• Review both paper and electronic CRFs, assisting with data query resolutions.

• Aid sites in maintaining the Investigator Site File.

• Maintain consistent communication with sites.

• Update site-related documentation for inclusion in the Trial Master File.

• Ensure site compliance regarding the receipt, accountability, return, or destruction of investigational products.

• Conduct accompanied site visits for CRA evaluations or training purposes.

• Complete final site close-out visits and reports.

• Guarantee the quality and prompt submission of site data, including safety event reporting and follow-up.

⛳️ Requirements

• Medical Doctor (MD) degree or a Pharmacist degree (MSPH, PharmD, PhD, or equivalent Pharmacy degree, etc.) with a minimum of three years of experience as a Clinical Research Associate.

• Bachelor’s degree with a major in medical, biological, physical, health, pharmacy, or another related science and at least five years of experience as a Clinical Research Associate.

• Associate degree or equivalent education/training with a minimum of seven years of experience as a Clinical Research Associate.

• Willingness to travel as required.

• Valid current passport necessary.

• Possession of a driving license.

• Fluency in the local languages of the countries for which responsibilities are held.

• Proficient in both spoken and written English.

• Comprehensive understanding of clinical research principles and processes.

• In-depth knowledge of FDA and/or EU Directives and regulations, ICH Guidelines, and local regulatory requirements.

• Strong understanding of two to three therapeutic areas.

• Familiarity with standard operating procedures.

• Proficient in Microsoft Office applications.

• Experienced with IxRS and EDC systems.

• Exceptional oral and written communication, planning, organizational, interpersonal, initiative, problem-solving, leadership, and time-management skills.

🏝️ Benefits

• A diverse and inclusive work environment.

• Supportive and collaborative teams.

• Accessible and hands-on leadership.

• Equal employment opportunities for all.

• Employee experiences centered around appreciation, inclusion, creativity, innovation, and success.