CoGuide is dedicated to transforming the global research ecosystem through innovative technology solutions, expert mentoring, and top-quality research support services. Partnering with a wide range of organizations, including corporate health sectors, medical institutions, and NGOs, CoGuide aims to advance scientific evidence and representation across diverse settings.
Job Overview
The Clinical Trial Research Associate role at CoGuide is an exciting opportunity to contribute to groundbreaking medical research. You will play a pivotal role in coordinating clinical trials, managing data, maintaining regulatory compliance, and collaborating with multidisciplinary teams to ensure the successful execution of clinical studies.
Key Responsibilities
1. Clinical Trial Coordination
- Assist in planning and executing clinical trials in accordance with protocol specifications and regulatory guidelines.
- Ensure adherence to timelines and high-quality standards.
2. Data Collection and Management
- Collect, record, and manage clinical trial data with precision.
- Maintain compliance with data integrity and confidentiality protocols.
3. Documentation and Compliance
- Organize trial documentation, including regulatory submissions, study protocols, and informed consent forms.
- Ensure all activities comply with Good Clinical Practice (GCP) guidelines and relevant regulatory frameworks.
4. Collaboration and Communication
- Work closely with investigators, clinical research coordinators, data managers, and regulatory affairs teams.
- Foster effective communication for seamless coordination of study activities.
5. Adverse Event Reporting
- Accurately report adverse events, protocol deviations, and safety-related issues to regulatory authorities and Institutional Review Boards (IRBs).
Required Qualifications
- Education: Bachelor’s degree in life sciences, nursing, pharmacy, or a related field.
- Experience: Previous clinical research experience (preferably in a clinical trial setting) is advantageous.
- Certifications: GCP certification.
- Skills:
- Familiarity with regulatory requirements, including GCP, FDA regulations, and ICH guidelines.
- Proficiency in electronic data capture systems and data management tools.
- Excellent written and verbal communication skills.
Preferred Qualifications
- Master’s degree in life sciences, pharmacy, or a related field.
- A minimum of 3 years of experience in clinical research.
- Strong ability to work both independently and collaboratively.
Key Competencies
- Ethical commitment to maintaining integrity in clinical research.
- Exceptional organizational and problem-solving skills.
- Expertise in managing data and ensuring compliance with regulatory standards.
