HonorHealth Research Institute · 8 hours ago
Senior Clinical Research Coordinator
Scottsdale, AZ
Full-time
Onsite
Mid, Senior Level
$64K/yr - $82K/yr
4+ years expHonorHealth Research Institute is seeking a Senior Clinical Research Coordinator who is experienced and demonstrates autonomy in managing complex protocols. The role involves coordinating clinical research activities, mentoring new staff, and ensuring compliance with study protocols and quality standards.
Research
Responsibilities
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 screening, recruitment, obtaining informed consent, 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: collecting, verifying, organizing, completes and records clinical information and data in case report forms, CRF tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation, query resolution and recording clinical information and data in case report forms, safety coding. 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 maintenancety 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 regards 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
Qualification
Required
Bachelor's Degree or 4 years' work related experience in Health Science
4 years of progressively responsible clinical or data management experience
Basic Life Support (BLS)
Preferred
Bachelor's Degree in Health Science
Other Experience in pharmaceutical sponsored and investigator initiated clinical research trials in the therapeutic area
Other Proficiency in MS Word, outlook, PowerPoint, Excel, EDC (electronic data capture) Knowledge of ICH/GCP, FDA regulations for clinical trials Excellent written and verbal communication skills
Clinical Research Certification
IATA Certification
Company
HonorHealth Research Institute
HonorHealth Research Institute is an international destination that is at the forefront of providing patients with a better quality of life through access to clinical trials and innovative treatment options.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Chad Adams, MPH
AVP | Chief Operational Officer
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