The Role
Manage complex clinical research protocols, including data collection, entry, validation, query resolution, database maintenance, subject follow-up, quality checks, regulatory reporting, training/precepting staff, and process improvement to support investigators and sponsors.
Summary Generated by Built In
Primary City/State:
Shea Medical Office Building - 10290 N 92nd St Scottsdale, AZ 85258Category:
Research OperationsShift:
DayDepartment:
HRI-Data CoordinationMonday-Friday 8am-4:30pm
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 Research Data III is an experienced coordinator who demonstrates autonomy in the management of complex protocols, precepting and mentoring of new research staff, and assisting in quality review and process improvement. This position supports our organization's efforts to achieve service excellence to our patients, investigators, and sponsors.
ESSENTIAL FUNCTIONS
- Responsible for the coordination management of complex protocols (multi-arm, multi-disciplinary, etc.). May be the sole coordinator on studies. May be responsible for activities such as the creation and review of source documents, data collection, data entry, query resolution, triggering financial payments, study startup/close out. May be responsible for the following: verifying, organizing, recording data in case report forms, CRF tracking, reviewing validation, updating, SAE reconciliation, reconciliation, query resolution and recording clinical information and data in case report forms, . Enters, validates, and audits clinical research data across electronic data capture systems. Assists with subject follow-up for clinical protocols and documents/report clinical study progress to assigned study team. Obtains all reports and submits data forms and pathology and radiology materials according to protocol requirements. Conducts protocol administration quality control monitoring, enforcement and database maintenance coding. Conducts protocol administration quality control monitoring and enforcement. May be responsible for database maintenance. Acts as the liaison with the sponsor/CRO.
- Assists with creation & implementation of tools to continuously improve team’s performance. Communicates department’s measurable improvements & positive trends to management. Assists with team guidelines adherence to timely preparation of study documents, data entry, and data locks.
- Precepting and training on new systems and programs applicable to study coordination for research staff, including but not limited to coordination team, research nurses, infusion nurses, program managers, and regulatory affairs personnel.
- Tracking and reporting of weekly workload & progress. Assist in development and implementation of departmental operating procedures. Represents coordination team in budget development related meetings. May assist in the creation of business development proposals by supplying coordination related information and costs. Maintains communication flow in regard to study budget agreements, and budget amendments through the term of the project Collecting, organizing, and reviewing data as well as the development of data points for IIT trials.
- Assists leadership with conduct of monthly quality checks of recorded data, verification of proper documentation, deviations, and compliance with timelines. Assists with identification & documentation of regulatory and protocol deviation findings. Analyzes findings and communicates potential solutions to management. Verification of proper reporting of events, including IRB reporting. Providing observations and feedback on IIT data at various study timepoints. Provides assistance to peers to ensure that study deadlines are met (data entry, query resolution, source document creation, review of study start up materials).
- Performs other related duties as assigned
EDUCATION
- Bachelors or 4 years' work related experience in Health Science Required
- Bachelors n Health Science Preferred
EXPERIENCE
- 4 years, of progressively responsible research or data management experience Required
- Other, Experience in pharmaceutical sponsored and investigator initiated clinical research trials in the therapeutic area. Preferred
- Other, Knowledge of ICH/GCP, FDA regulations for clinical trials. Preferred
- Other, Excellent written and verbal communication skills Preferred
- Other, Proficiency in MS Word, outlook, PowerPoint, Excel, EDC (electronic data capture) Preferred
LICENSE AND CERTIFICATIONS
- IATA Certification Preferred
- Clinical Research Certification Preferred
We're all in for your career.
Skills Required
- Bachelors or 4 years' work related experience in Health Science
- 4 years of progressively responsible research or data management experience
- Experience in pharmaceutical sponsored and investigator initiated clinical research trials in the therapeutic area
- Knowledge of ICH/GCP and FDA regulations for clinical trials
- Excellent written and verbal communication skills
- Proficiency in MS Word, Outlook, PowerPoint, Excel, EDC (electronic data capture)
- IATA Certification
- Clinical Research Certification
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The Company
What We Do
This practice is a dedicated team of electrophysiologists, physician assistants, nurses and technicians, who as a group, are committed to treating and caring for patients experiencing problems with their heart's rhythm and electrical signaling.
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