Coordinator II - Clinical Research Bariatric GI

HonorHealth; Scottsdale (AZ); On-site; USD 55,000 - 75,000; Full time

Job summary

HonorHealth is seeking a Clinical Research Coordinator to oversee clinical data management in Scottsdale, AZ. The role includes tasks like recruitment, data collection, and quality control monitoring across clinical protocols.

The successful candidate will have at least 2 years of relevant experience, preferably in pharma, and a bachelor's in health science or equivalent. Strong communication and project management skills are essential, along with familiarity with regulatory compliance.

Qualifications

• In Health Science or 4 years of health science-related experience.
• 2 years of progressively responsible clinical/clinical research or data management experience required.
• Knowledgeable of ICH/GCP and FDA regulations for clinical trials.

Responsibilities

• Responsible for clinical data management of complex protocols.
• Assists with weekly tracking and reporting of team's workload.
• Precepting and training on new systems and programs.

Skills

Clinical data management

Communication

Project management

MS Word

MS Excel

Electronic data capture (EDC)

Education

Health Science or 4 years of health science-related experience

Tools

Access

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

Responsibilities

• 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
• 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