HonorHealth Research Institute · 20 hours ago
Coordinator II - Clinical Research
Scottsdale, AZ
Full-time
Onsite
Entry, Mid Level
$61K/yr - $78K/yr
2+ years expHonorHealth Research Institute is seeking a Coordinator II for Clinical Research to manage day-to-day project activities and resources for clinical trials. The role involves clinical and data management, recruitment, data collection, and ensuring compliance with protocols and regulations.
Research
Responsibilities
Responsible for clinical and/or data management of complex protocols. May be involved in many of the following activities: recruitment, screening, obtaining informed consent, reviewing source documents, data collection, data entry, query resolution, triggering financial payments, study startup/close out. Serves as a liaison with sponsor. Collects, verifies, organizes, completes and records clinical information and data in case report forms. May be involved in many of the data related activities: CRF tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation, resolve queries and safety coding. 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, enforcement and database maintenance. 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
Qualification
Required
Bachelor's Degree in Health Science or 4 years of health science-related experience
2 years of progressively responsible clinical/clinical research or data management experience
Basic Life Support (BLS)
Preferred
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)
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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