Coordinator II - Clinical Research Bariatric GI

10 John C. Lincoln Medical Center; Scottsdale (AZ); Presencial; USD 65 000 - 90 000; Tempo integral

Resumo da oferta

HonorHealth Research Institute in Scottsdale is seeking a Coordinator-Clinical Research II to manage day-to-day execution of clinical trials and provide clinical data support in compliance with FDA, ICH, and GCP guidelines.

The role collaborates with research staff to collect, verify, and maintain data, handle data forms, and assist with study startup/close-out while ensuring regulatory documentation and quality checks are met.

Qualificações

• 2 years of progressively responsible clinical/clinical research or data management experience required
• Knowledge of ICH/GCP and FDA regulations for clinical trials preferred
• Strong writing and computer skills (Word, Excel, Access, EDC) preferred

Responsabilidades

• Manages day-to-day execution of clinical trials and provides clinical data support for the conduct of trials
• Collects, verifies, organizes, and records clinical information in accordance with FDA, ICH, and GCP guidelines
• Performs data management tasks including recruitment support, source document review, data collection, and query resolution
• Supports protocol administration, site initiation, interim monitoring, and study close-out visits as needed
• Precepts and trains staff on data management procedures and systems

Conhecimentos

Clinical data management

Project management

Regulatory knowledge

Documentation

MS Word

Formação académica

Health Science degree or 4 years health science-related experience

Ferramentas

MS Word

Excel

Access

EDC (electronic data capture)

Descrição da oferta de emprego

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 the health and well-being of 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.

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
• Other, Experience in pharmaceutical sponsored and investigator initiated clinical research trials in the therapeutic area. Preferred
• Other, Knowledgeable of ICH/GCP, FDA regulations for clinical trials and strong project management skills Preferred
• Other, Strong writing and computer skills, including, MS Word, Excel, Access, EDC (electronic data capture) Preferred

LICENSE AND CERTIFICATIONS

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

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