Contributes to clinical research study implementation and management by participating in investigator meetings, initiation, training, and monitoring study sites, maintaining documentation, report preparation, including protocols and final integrated reports, and providing general oversight for studies. Performs Internal/External quality audits, complaint investigations, and assists in the maintenance of the subsystems of the Quality System.
ESSENTIAL FUNCTIONS PERFORMED
- Conducts clinical site monitoring, initiation, and training activities including document management, safety reporting and monitoring reports.
- Ensures site compliance with clinical trial protocol, FDA and ICH/GCP's guidelines.
- Provides oversight to imaging centers, labs, supply vendors and other study vendors.
- Assists in the development and review of clinical study documents including informed consent forms, operational plans, and case report forms (CFR's).
- Communicates with Clinical Research Investigators.
- Assists with creation of training materials and guidelines, and other project-related and/or department-related duties.
- Receives and reviews all clinical regulatory documents from sites for accuracy and compliance to company SOPs and federal guidelines, tracks all information for reference, and maintains documentation as required. Ensures that clinical regulatory documents are updated in a timely and appropriate manner.
- Tracks and manages incoming study documentation, including imaging and CRF's.
- Supports all quality systems within the company.
- Assists with obtaining market clearance in the United States (510'k, IDE, PMA)
- Maintains Technical Files.
- Acts as internal and external quality auditor.
- Assists in International Product Registrations.
- Investigates product returns for complaint analysis.
- Performs other related duties and tasks, as required.
SUMMARY OF MINIMUM QUALIFICATIONS
- Education and/or experience equivalent to a Bachelor's Degree in a scientific discipline and four years of related experience.
- Knowledge of FDA, ISO 13485, SOP, MDD standards, and GMP requirements within the medical device industry.
- Knowledge of Good Clinical Practice Regulations and ICH guidelines.
- Demonstrated knowledge of regulatory affairs.
- Demonstrated human relations and effective communication skills -- verbal and written.
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
- Strong organizational skills and the ability to be self-motivated and be detailed oriented.
- Ability to travel to clinical sites, domestic and foreign, up to 50%.
- Document packaging and coordination for:
- Regulatory submissions (domestic and international)
- Facilitates corrective actions on internal audits
- Governmental inspections
- Medical Device Reports
- Clinical trials
- Company policies and procedures
- Management/external agency/company interaction.
- Project task team participation