Coordinator II - Clinical Research Bariatric GI

Responsibilities

• Manages day-to-day execution of clinical trials across the research institute.
• Provides clinical data support for the conduct of clinical research at HonorHealth Research Institute.
• Works closely with all Research Staff to collect, store and maintain data in accordance with FDA Regulations, International Council of Harmonization, and Good Clinical Practices.
• Responsible for clinical data management of complex protocols.
• May be involved in many of the following activities: recruitment, screening, obtaining informed consent, reviewing source documents, data collection, query resolution, triggering financial payments, study startup/close out.
• Serves as a liaison with sponsor.
• Collections, verifies, organizes, completes and records clinical information.
• Aids in subject follow-up for clinical protocols and documents/report clinical study progress as required.
• Obtains all reports and submits data forms and pathology and radiology materials according to protocol requirements.
• Conducts protocol administration quality control monitoring.
• May participate in site initiation, interim monitoring, and study close out visits with sponsor and FDA initiated audits as needed.
• May be required to handle and label samples and ship samples according to protocol requirements.
• Facilitates ongoing set up and closing of clinical protocols.
• Aids in the creation and implementation of tools to continuously monitor team performance.
• Communicates departments measurable improvements and positive trends to management.
• Aids in the creation and implementation of departmental operating procedures.
• Represents coordination team in a variety of meetings.
• May assist in the creation of business development proposals by supplying coordination related information and costs.
• Aids leadership with conduct of monthly quality check of recorded and submitted data.
• This includes the verification of proper documentation of the data, deviations, and compliance with deadlines.
• Assists with the identification and documentation of regulatory and protocol deviation findings, including IRB reporting.
• Provides assistance as needed to peers to ensure that study deadlines are met.
• Identifies data management project issues and alerts leadership and makes recommendations.
• Maintains communication with supervisor regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practices.
• Performs other related duties as assigned.
• Performs other duties as assigned.

Qualifications

• Education in Health Science or 4 years of health science-related experience.
• Experience in clinical/clinical research or data management, 2 years of progressively responsible experience.
• Knowledgeable of ICH/GCP, FDA regulations for clinical trials and strong project management skills.
• Strong writing and computer skills, including, MS Word, Excel, Access, EDC (electronic data capture).
• Basic Life Support (BLS) - Certification, Required.
• Clinical Research Certification Preferred.
• IATA Certification Preferred.