Pharmaceutical Research Specialist
2 days ago
As a Pharmaceutical Research Specialist, you will be responsible for leading and reporting on-site monitoring visits to ensure data integrity and compliance with regulatory requirements.
You will participate in site feasibility, selection, and study start-up to identify potential challenges and opportunities for improvement.
Additionally, you will perform CRF review, SDV, and query resolution to ensure accurate and complete data collection.
Key Responsibilities:- Conduct and report all types of on-site monitoring visits to ensure data integrity and compliance with regulatory requirements.
- Participate in site feasibility, selection, and study start-up to identify potential challenges and opportunities for improvement.
- Perform CRF review, SDV, and query resolution to ensure accurate and complete data collection.
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or equivalent.
- ~2 years of independent on-site monitoring experience in Australia (slightly less may be considered).
- Solid experience in monitoring visits across Phases II and/or III.
- Knowledge of study start-up and feasibility assessment is preferred.
- Therapeutic area experience in IBD, Oncology, or Infectious Diseases is an advantage.
- Full working proficiency in English.
- Proficient in MS Office (Word, Excel, PowerPoint).
- Strong planning, multitasking, communication, and problem-solving skills.
- Willingness to travel as required.
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