Job Title: Clinical Research Associate
Position Summary: Responsible for implementing and monitoring clinical studies of new and modified products. Assists with preparation of clinical protocols, study progress reports and clinical trial reports.
Essential Duties and Responsibilities:
- Knowledge of regulations and standards affecting products. Complies with all polices, established procedures, and regulations related to clinical research, including 21CFR Parts 50, 56 & 58.
- Assists with preparation of clinical protocols, informed consent, clinical trial report, and other required documents for clinical studies. Assists with responses to regulatory agency questions pertaining to clinical studies.
- Initiates legal documents including Non-disclosure Agreements and Clinical Trial Agreements. Proposes and negotiates budgets for clinical studies. Initiates and track payments to sites ensuring budget adherence.
- Assists with obtaining and reviewing all required essential documents necessary for study initiation.
- Initiates clinical studies and provides investigator and staff training. Monitors clinical studies, ensuring site compliance with the clinical protocol and GCP guidelines; assures subject rights, safety, and welfare are protected; ensures data integrity through completeness, accuracy and legibility.
- Assists Data Management and Statistics with the collection and querying of clinical data and tracking of enrollment at the clinical sites
- Prepares study updates to keep management informed.
- Minimum Bachelor’s Degree in science related field, or equivalent. Medical Technology background preferred.
- A minimum of 2 to 3 years of Clinical Research experience
- Experience working directly with clinical investigators and study sites
- Thorough understanding of FDA regulations and requirements for in vitro diagnostic devices.
- Good foundation in laboratory testing methodologies.
- Effective verbal and written communication skills
- Computer literacy to operate standard word processing, spreadsheets, presentation and internet application.
- Detail oriented with strong prioritization skills.
- Ability to travel up to 40% of time.
- Effective time management skills.