Coordinator I - Clinical Research

HonorHealth•Scottsdale, AZ

1d•Onsite

About The Position

The Coordinator Clinical Research I 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.

Requirements

High School Diploma or GED Required
2 years, experience working with data, or a technician working in a healthcare environment, or currently enrolled in/completed a research educational program or 1 year of experience as a clinical research admin support specialist at HonorHealth Research Institute Required
Basic Life Support (BLS) - Certification, Required

Nice To Haves

Bachelors Preferred
Healthcare related field Preferred
Strong writing and computer skills, including MS Word, Excel, EDC (electronic data capture) Preferred
IATA Certification Preferred

Responsibilities

Assists in the coordination and management of inpatient and outpatient studies, according to protocol and sponsor amendments.
Provides clinical management project support for multidisciplinary clinical research, including patient screening for study eligibility, obtaining informed consent and subject registration.
Collects, verifies, organizes and records clinical information and data in case report forms.
Abstracts data from necessary sources to complete all forms to the required quality.
Performs data related activities: CRF tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation and safety coding.
Assists with subject follow-up for clinical protocols.
Works with the research team to track study progress and may be involved in the development of periodic status reports.
May assist with the preparation of annual reports and statistical information on clinical research as required by the Institute, System. IRB, or investigators.
Assists with the creation and implementation of tools to continuously improve team’s performance.
Communicates department’s measurable improvements and positive trends to management.
Assists with team guideline adherence to timely preparation of study documents, data entry and data locks.
Participates in tracking and reporting of workload and progress.
Assists in development and implementation of departmental operation procedures.
Represents coordination team in study feasibility, implementation, and close out activities.
May assist in creation of business development proposals by supplying data and or patient management related information.
Maintains communication flow through the term of the study.
Assists with obtaining all reports and submits data forms and materials according to protocol requirements.
Identifies the achievement of key milestones such as draft or final database.
Provides assistance as needed to peer to ensure that study deadlines are met.
Mentoring and training on new systems and programs applicable to the coordinator role.
Provides support to Research Staff in execution of pharmaceutical or investigator initiated clinical protocols within scope of role.
Handles and labels samples and ships samples according to protocol requirements.
Maintains communication with the Research Staff regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practices.
Provides input and assistance to the Research Staff in maintaining the Regulatory Binders for all ongoing research studies in accordance with FDA regulations and sponsor requirements.
Maintains working relationships with external customers (e.g. professional research organizations and physicians).
Assists leadership with conduct of monthly quality check of data recorded and submitted.
This may include verification of proper documents of clinical data, deviations within a specific time period.
Assists with identification and documentation of regulatory and protocol deviation findings.
Analyzes findings and communicated possible solutions to leadership.
May be involved in verification of proper reporting of events, including IRB reporting.
Performs other related duties as assigned.
Performs other duties as assigned.