Job Summary The Research Data Coordinator II is the primary contact with the study sponsor and is responsible for the day-to-day management of project activities and resources and overall clinical data and protocol management for the conduct of therapeutic clinical trials at HonorHealth.
Collects, verifies, organizes, completes and records clinical information and data in case report forms. Performs the following 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 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.
Provides data management project leadership to support multi-disciplinary clinical trials, including patient screening for study eligibility, obtaining Informed consent and subject registration. Handles and labels samples and ships samples according to protocol requirements.
Track study/clinical trials progress and issues periodic status reports. Communicates the achievement of key milestones such as draft or final database to the project team.
Prepares annual reports and statistical information on all clinical research as required by System, IRB or investigators. Collaborates with Regulatory/IRB Coordinator as necessary.
Acts as liaison in support of pharmaceutical and investigator initiated clinical protocols. May participate in site initiation, interim monitoring, and study close out visits with sponsor and FDA initiated audits as needed. Handles and labels samples and ships samples according to protocol requirements. Facilitates ongoing set up and closing of clinical protocols. Represents data management at business development related meetings. May assist in the creation of business development proposals by supplying data management related information and costs.
Provides assistance as needed to peers to ensure that study deadlines are met. Identifies data management project issues and alerts senior department management with a view to recommendations. Maintains communication with supervisor regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practices. Participates in mentoring and training of staff on data management procedures, and systems, including the mentoring of all direct reports. Performs other related duties as assigned.
Internal Number: 2018-7256
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Welcome to HonorHealth.
We are a non-profit, local healthcare organization known for community service and outstanding medical quality. Our organization encompasses five acute care hospitals with approximately 10,500 employees and 3,100 volunteers, urgent care centers, clinical research, medical education, an inpatient rehabilitation hospital, an Accountable Care Organization, two foundations, and extensive community services.