
Clinical Research and Development Specialist
4 days ago
Key Responsibilities
- Design and implement clinical trial protocols and study plans.
- Coordinate site selection, initiation, monitoring, and close-out activities.
- Ensure compliance with Good Clinical Practice (GCP), FDA, and ICH guidelines.
- Monitor trial progress, data integrity, and subject safety.
- Prepare and review regulatory documents, informed consent forms, and case report forms.
- Collaborate with investigators, site staff, and internal teams to resolve issues and maintain timelines.
- Analyze clinical data and contribute to study reports and publications.
Qualifications
- Bachelor's or Master's degree in Life Sciences, Nursing, Pharmacy, or related field.
- 2–5 years of experience in clinical research or clinical trial management.
- Strong knowledge of GCP, clinical trial methodologies, and regulatory requirements.
- Experience with clinical trial management systems (CTMS) and electronic data capture (EDC).
- Certification from ACRP, SOCRA, or equivalent is a plus.
Technical Skills
- Proficiency in Microsoft Office Suite and clinical data management tools.
- Familiarity with statistical software (e.g., SAS, R) is an advantage.
- Ability to interpret complex clinical data and generate insights.
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