Senior Clinical Research Monitor

🔥 16 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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LIBBS FARMACÊUTICA LTDA

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1958

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

LIBBS FARMACÊUTICA LTDA is a Brazilian pharmaceutical company with a focus on producing biological medications and a commitment to innovation and research. Established for over 67 years, the company employs around 3,800 people and is recognized as one of the top laboratories in the pharmaceutical retail sector in Brazil. LIBBS specializes in various therapeutic areas, including cardiometabolic, dermatology, gastrointestinal, gynecological, hematological, oncological, respiratory, and central nervous system treatments, with over 100 product brands and a strong emphasis on improving patient health and well-being.

📋 Description

• Conduct, as needed and for training purposes, on-site or remote qualification/selection, initiation, monitoring, and close-out visits at research sites • Conduct visits when necessary during periods of high demand • Mentor and guide junior and mid-level monitors during monitoring activities • Ensure studies are conducted in compliance with the protocol, ICH-GCP, applicable regulations, and internal procedures • Verify the quality, integrity, and traceability of clinical data in CRFs/eCRFs • Support the development of the Monitoring Plan, Recruitment Plan, and other operational tools • Participate in meetings with research sites and multidisciplinary teams • Serve as a technical reference for the monitoring team • Conduct training and development sessions • Support the onboarding of new Clinical Operations employees • Serve as technical backup for monitoring coordination • Act as the primary point of contact between research sites, monitors, and Clinical Operations coordination • Assess site performance and suitability, identifying risks and proposing corrective and preventive actions • Support participant recruitment, retention, and engagement strategies • Technically review monitoring reports, follow-ups, and site letters • Ensure the Investigator Site File (ISF) is up to date and compliant • Track protocol deviations, adverse events, and nonconformities, identifying trends and following up on action plans • Participate in audits and inspections when necessary • Contribute to SOPs, work instructions, and Quality Management System documents • Ensure study timelines and targets are met • Support the development and monitoring of site and CRA team KPIs • Identify continuous improvement opportunities • Lead meetings with internal teams, sites, vendors, and stakeholders • Escalate risks and critical issues to management • Participate in the review of clinical protocols, informed consent forms (ICFs), eCRFs, operational plans, and study materials

🎯 Requirements

• Bachelor’s degree in a health sciences or biological sciences field, such as Pharmacy, Biomedicine, Physiotherapy, or Nursing • Intermediate English proficiency (reading and writing) • Proven experience as a CRA, with strong knowledge of GCP and national and international regulations • Knowledge of the ethics submission process (CEP/CONEP) • Understanding of clinical protocols, CRFs (Case Report Forms), and monitoring procedures (initiation, monitoring, and close-out visits) • Familiarity with eCRF and EDC systems, such as Medidata Rave, Oracle InForm, and Veeva Vault • Specialization in Clinical Research (preferred) • Master’s or doctoral degree (preferred) • Previous experience at CROs and/or as a technical point of contact or CRA coordination lead (preferred) • Knowledge of Se Suite, Veeva eTMF / CTMS (preferred) • Willingness to travel (50% of the time for training, when necessary, and during peak demand periods)

🏖️ Benefits

• Meal allowance • Food allowance • 100% coverage for Libbs medications • Pharmacy benefit – Vidalink • Profit Sharing and Results Program (PPR) • Parking, transportation allowance, or company shuttle • USE Program: subsidy toward the purchase of equipment used for work, which may also be used for personal purposes • Flexible benefits (TotalPass, life insurance, private pension, medical and dental coverage, and food allowance) • Remote work • Flexible working hours • Access to coworking spaces worldwide