Clinical Research Associate Jobs – Research Jobs at IQVIA
IQVIA Biotech is a leading global provider of advanced analytics, technology solutions, and clinical research services to the biotechnology industry. We are dedicated to improving the health and welfare of patients worldwide through scientific research and innovation. As a Senior Clinical Research Associate, you will play a vital role in ensuring the successful execution and monitoring of clinical studies in accordance with regulatory guidelines and project requirements.Clinical Research Associate Jobs – Research Jobs at IQVIA. Interested Candidates can check out the detail below and Apply.
Job Position: Senior Clinical Research Associate
Location: Brazil – IQVIA Biotech
Job Details
- Primary Location: Sao Paulo, Brazil
- Employment Type: Full time
- Job ID: R1385207
Essential Functions
- Perform site monitoring visits: Conduct site selection, initiation, monitoring, and close-out visits to ensure compliance with study protocols, regulations, and sponsor requirements.
- Subject recruitment: Collaborate with sites to develop and track subject recruitment plans in alignment with project needs.
- Training and communication: Administer protocol and study-related training to assigned sites and establish regular communication channels to address project expectations and issues.
- Quality assessment: Evaluate the quality and integrity of study site practices and escalate quality issues as necessary.
- Study progress management: Track regulatory submissions, approvals, recruitment, case report form completion, data queries, and resolution.
- Document management: Ensure appropriate filing of site documents in Trial Master File (TMF) and maintenance of Investigator’s Site File (ISF).
- Reporting and documentation: Create and maintain accurate documentation of site visits, findings, action plans, and other required study documentation.
- Mentorship and training: Act as a mentor for clinical staff, including conducting co-monitoring and training visits.
- Collaboration and support: Collaborate with study team members to provide project execution support.
- Subject recruitment planning: Support the development of project subject recruitment plans on a site-specific basis, if applicable.
- Financial management: Accountable for site financial management according to clinical trial agreement and local requirements.
Qualifications
- Bachelor’s Degree: Degree in scientific discipline or healthcare preferred.
- Experience: 4+ years of on-site monitoring experience.
- Regulatory knowledge: In-depth understanding and application of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Therapeutic and protocol knowledge: Strong knowledge in relevant therapeutic areas and protocols.
- Computer skills: Proficiency in Microsoft Word, Excel, PowerPoint, and ability to use a laptop computer, iPhone, and iPad (where applicable).
- Communication skills: Excellent written and verbal communication skills, including fluency in English.
- Organizational and problem-solving skills: Detail-oriented with strong organizational and problem-solving abilities.
- Time and financial management skills: Effective time and financial management abilities.
- Interpersonal skills: Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Additional Requirements
- Minimum 2 years of monitoring experience
- Oncology experience preferred: Solid tumor and Hematology / early phase
- Other therapeutic experience valuable: Internal medicine and Cardiovascular/Renal
