Clinical Research Specialist
1 week ago
**Job Summary**:
We are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to support the timely and efficient initiation and execution of multi-center clinical studies, including Health Economics and Outcomes Research (HEOR). This role is pivotal in managing the study process from site feasibility and qualification through to initiation and execution, ensuring compliance with all regulatory and ethical standards.
**Key Responsibilities**:
- Coordinate and manage site feasibility, site qualification, study start-up, and execution activities under the direction of the Clinical Operations Manager and lead scientists.
- Ensure timely collection, review, and maintenance of essential study documents in compliance with ICH GCP, country-specific regulations, and Abbott SOPs.
- Monitor and support clinical study sites to ensure high-quality data collection and adherence to study protocols and timelines.
- Serve as the primary liaison with clinical research sites and Key Opinion Leaders (KOLs), maintaining strong collaborative relationships.
- Oversee the execution of key clinical activities for Abbott Nutrition studies, including therapeutic, pediatric nutritional, and efficacy studies.
- Support budget management, timeline tracking, and risk mitigation across study sites to ensure successful project outcomes.
**Qualifications**:
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
- Minimum 5 years of experience in clinical research, preferably within nutritional, pharmaceutical, or healthcare sectors.
- Strong understanding of clinical trial processes, GCP, and local regulatory requirements.
- Excellent organizational, communication, and stakeholder management skills.
- Ability to travel to research sites as needed.
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