Coordinator I - Clinical Research
About The Position
The Coordinator Clinical Research I manages the day-to-day execution of clinical trials across the research institute and provides clinical data support for research conducted at HonorHealth Research Institute. The position works closely with Research Staff to collect, store, and maintain data in accordance with FDA regulations, International Council for Harmonisation requirements, and Good Clinical Practices. The coordinator supports inpatient and outpatient studies, including participant screening, informed consent, registration, follow-up, data collection and entry, sample handling and shipment, and study documentation. The role also contributes to study tracking, quality checks, regulatory compliance, process improvement, feasibility, implementation, and closeout activities. The position maintains communication with Research Staff and external customers throughout the study and provides peer support, mentoring, and training on relevant systems and programs.
Requirements
- High school diploma or GED required.
- Two years of experience working with data, working as a technician in a healthcare environment, or being currently enrolled in or having completed a research educational program; alternatively, one year of experience as a clinical research administrative support specialist at HonorHealth Research Institute.
- Basic Life Support (BLS) certification required.
Nice To Haves
- Bachelor’s degree preferred.
- Experience in a healthcare-related field preferred.
- Strong writing and computer skills, including MS Word, Excel, and electronic data capture (EDC), preferred.
- IATA certification preferred.
Responsibilities
- Assist in coordinating and managing inpatient and outpatient studies in accordance with protocols and sponsor amendments.
- Provide project support for multidisciplinary clinical research, including screening patients for eligibility, obtaining informed consent, and registering subjects.
- Collect, verify, organize, and record clinical information and data in case report forms; abstract data from source materials to complete forms accurately.
- Perform data-related activities, including case report form tracking, validation review, updates, serious adverse event reconciliation, laboratory data reconciliation, and safety coding.
- Assist with subject follow-up for clinical protocols.
- Track study progress with the research team and contribute to periodic status reports; assist with annual reports and statistical information as required.
- Help create and implement tools to improve team performance, communicate measurable improvements and positive trends to management, and support adherence to team guidelines and deadlines for study documents, data entry, and data locks.
- Participate in tracking and reporting workload and progress, and assist in developing and implementing departmental operating procedures.
- Represent the coordination team in study feasibility, implementation, and closeout activities.
- Provide data or patient-management information for business development proposals as needed and maintain communication throughout the study.
- Obtain required reports and submit data forms and materials according to protocol requirements; identify key milestones, such as draft or final databases.
- Provide peer assistance to help meet study deadlines and mentor or train staff on systems and programs applicable to the coordinator role.
- Support Research Staff in executing pharmaceutical or investigator-initiated clinical protocols within the scope of the role.
- Handle, label, and ship samples according to protocol requirements.
- Communicate with Research Staff about regulatory and safety issues and concerns related to Good Clinical Practices.
- Assist Research Staff in maintaining regulatory binders in accordance with FDA regulations and sponsor requirements.
- Maintain working relationships with external customers, including professional research organizations and physicians.
- Assist leadership with monthly quality checks of recorded and submitted data, including verification of clinical data documentation and deviations within specified time periods.
- Assist in identifying and documenting regulatory and protocol deviations, analyze findings, and communicate possible solutions to leadership; may verify appropriate reporting of events, including IRB reporting.
- Perform other related duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
