SUMMARY OF DUTIES

Supervises the clinical research and clinical trial associates team to ensure the proper tracking and documentation of investigator meetings, initiations, trainings, and monitoring, and overall Trial Master File (TMF) compliance. Provides general oversight for CRA/CTA activities for applicable studies. Supervisor is provided a study for oversight as well.

ESSENTIAL FUNCTIONS PERFORMED

1. Oversees and manages for assigned study(s) all applicable trackers per study, including but not limited to, TMF, outstanding action items and resolution plans, monitoring, etc.
2. Oversees and manages other CRAs within the department.
3. Ensures compliance with clinical trial protocol, FDA and ICH/GCP's guidelines.
4. Provides oversight in collaboration with Project Manager to imaging centers, labs, supply vendors and other study vendors.
5. Develops and reviews clinical study documents including templates, logs, and trackers.
6. Manages department personnel by interviewing, hiring, training, evaluating job performance, disciplining, scheduling work and other related responsibilities.
7. Communicates with Clinical Research Investigators, if required.
8. Creates training materials and guidelines, and other project-related and/or department-related duties.
9. 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 and applicable study trackers are updated in a timely and appropriate manner.
10. Manages and provides quality review of incoming study documentation, including essential documents, imaging and CRF's, as applicable.
11. Supports all quality systems within the department.
12. 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 six years of related experience, three years of which include management 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%.

COMPETENCIES

• Document packaging and coordination for:
• Regulatory submissions (domestic and international)
• Medical Device Reports
• Clinical trials
• Company policies and procedures
• Project task team participation
• People management
• Computer skills