Coordinator II - Clinical Research Bariatric GI

30 Shea Medical Center; Scottsdale (AZ); On-site; USD 65,000 - 90,000; Full time

Job summary

HonorHealth Research Institute is seeking a Coordinator-Clinical Research II to oversee day-to-day execution of clinical trials and provide data support across the research institute. The role partners with Research Staff to collect, store, and maintain data in compliance with FDA regulations and ICH/GCP guidelines.

You will manage data quality, assist with study startup and close-out activities, and help prepare documents and reports for sponsor and audits.

Qualifications

• 2 years of progressive clinical/research or data management experience required.
• Knowledgeable of ICH/GCP, FDA regulations for clinical trials.
• Strong writing and computer skills, including MS Word, Excel, Access, EDC.

Responsibilities

• Manage clinical data for complex protocols.
• Coordinate data collection, verification, and data entry.
• Liaise with sponsor and monitor data quality.
• Assist with study startup/close-out activities and reports.
• Support regulatory and safety documentation.

Skills

Clinical data management

Regulatory compliance

Clinical research basics

Documentation skills

Education

Health science degree or equivalent

Tools

MS Word

Excel

Access

EDC

Job description

Primary City/State: Shea Medical Office Building - 10150 North 92nd Street Scottsdale, AZ 85258
Category: Research Operations
Shift: Day
Department: HRI-Clinical Research Coordination
Monday - Friday

Great care starts with great people. (Like you.) At HonorHealth, you’ll find something special. From humble beginnings in 1927 to one of Arizona’s largest nonprofit healthcare systems, our culture is built on warmth and neighborly kindness. Behind every smile is a highly skilled professional with deep expertise and an unwavering dedication to what matters most — caring for people and communities across the greater Phoenix area.

Responsibilities

JOB SUMMARY The Coordinator-Clinical Research II manages day-to-day execution of clinical trials across the research institute. Position provides clinical data support for the conduct of clinical research at HonorHealth Research Institute. The position 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.

ESSENTIAL FUNCTIONS

• 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.
• Collects, verifies, organizes, completes and records clinical information.
• Assists with 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.
• Assists with creation and implementation of tools to continuously monitor team performance.
• Communicates departments measurable improvements and positive trends to management.
• Assists with team guideline adherence to timely preparation of study documents, data entry, and data locks.
• Precepting and training on new systems and programs applicable to the coordination role.
• Assists with weekly tracking and reporting of team’s workload and progress.
• Assists in development 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.
• Assists 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 peer 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.
• Participates in precepting and training of staff on data management procedures, and systems.
• Performs other related duties as assigned.
• Performs other duties as assigned.

Education

in Health Science or 4 years of health science-related experience

Experience

2 years, of progressively responsible clinical/clinical research or data management experience Required

Preferred

• Other, Experience in pharmaceutical sponsored and investigator initiated clinical research trials in the therapeutic area.
• 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).

License and Certifications

• Basic Life Support (BLS) - Certification, Required
• Clinical Research Certification Preferred
• IATA Certification Preferred

We're all in for your career. Expert care from experts who care. At HonorHealth, you’ll find something special. Our culture is built on warmth and neighborly kindness, but behind every smile is a highly skilled professional with deep expertise and unwavering dedication. We’re delivering a healthcare experience that simply feels better through:

• Nine acute-care hospitals
• Over 200 primary, specialty and urgent care centers
• More than 17,000 team members and 4,000 medical staff

Since 1927, we’ve been focused on doing what matters most — caring for people and communities across the greater Phoenix area. From humble beginnings to one of Arizona’s largest nonprofit healthcare systems, we’re just as driven as we were a century ago.

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