Medical Research Professional
7 days ago
We are seeking a skilled Medical Research Professional to join our client's team in Richmond. This is an exciting opportunity for a detail-oriented individual with experience in clinical operations to contribute to the development and commercialization of medical diagnostics.
Job Description:- We are looking for a highly motivated Clinical Research Associate to work out of our state-of-the-art facility in Richmond, collaborating with regulatory authorities and ethics committees to ensure compliance with industry protocols and local regulations.
- Study Design and Execution: The successful candidate will design, create, and write trial protocols and study documentation, including ethics applications, and liaise with regulatory authorities to integrate bioLytical product knowledge.
- Data Analysis and Reporting: Conduct data analysis, compile and generate scientific reports, regulatory documentation, and research-related documents.
- Site Monitoring and Training: Ensure study sites and activities adhere to appropriate industry protocols and terms of study by training and overseeing site staff on bioLytical product tests, therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
- Liaison and Communication: Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects, conduct and document study monitoring/site visits, coordinate project meetings, and implement actions for sites not meeting expectations.
- Inventory Management and Compliance: Oversee and document investigational product dispensing inventory, manage clinical and trial materials, ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
- Bachelor's degree in Biological Science or a related field.
- Minimum 3 years of experience in clinical operations.
- Knowledge of the diagnostics industry, terminology, and practices and FDA regulations and their practical implementation.
- Strong background in statistical data collection, validation, editing, and analysis techniques.
- Superior problem-solving, deductive reasoning, and decision-making skills.
- Strong verbal and written communication skills.
- Proficient computer skills, with Microsoft Office Word, Excel, and PowerPoint.
- Good time management and ability to prioritize tasks and accomplish set goals efficiently.
The estimated salary for this position is between $80,000 and $110,000 per year, depending on experience.
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