| Job Description: | Research Coordination and Study Support - Support the conduct of clinical research studies and clinical trials in compliance with approved protocols, Good Clinical Practice (GCP), institutional policies, and applicable regulatory requirements.
- Screen potential research participants and assist with patient recruitment and enrollment activities.
- Participate in the informed consent process and assist with educating participants and families regarding study procedures, requirements, interventions, and follow-up activities.
- Coordinate protocol-related study visits, research procedures, and participant follow-up activities.
- Schedule participant visits, testing, and study-related procedures.
- Maintain accurate and complete study source documentation and research records.
- Perform data collection and accurate data entry into study databases, case report forms (CRFs), and electronic data capture systems.
- Assist with the resolution of data queries and routine data quality review activities.
- Collect, process, and ship laboratory specimens as required by study protocols.
- Support participant safety by identifying and reporting adverse events and protocol deviations in accordance with study and institutional requirements.
- Assist with study monitoring visits, audits, site initiation activities, and study closeout procedures.
- Maintain essential regulatory documents and assist with the preparation and submission of regulatory materials to the Institutional Review Board (IRB) and other oversight bodies.
- Assist with study registration and maintenance activities in ClinicalTrials.gov as assigned.
- Retain and archive study records in accordance with institutional and sponsor requirements.
- Participate in promoting Human Subjects Protection and ethical conduct of research activities.
Clinical Outcomes Data Collection and Management - Serve as a primary coordinator for collection of patient-reported outcome measures (PROMs) and other clinical outcomes data for Spine Program research studies and quality initiatives.
- Administer, track, and manage PROM collection throughout the patient care continuum, including preoperative and postoperative follow-up periods.
- Monitor completion rates and conduct participant outreach to improve data collection and retention.
- Maintain outcomes databases and ensure accuracy, completeness, and integrity of collected data.
- Assist with tracking clinical outcomes and quality metrics for Spine Program research projects and programmatic initiatives.
- Generate routine reports and summaries of study enrollment, follow-up status, and outcomes data.
- Support development and maintenance of data collection tools, dashboards, and reporting processes used for research and quality improvement initiatives.
- Collaborate with clinical staff, providers, and research personnel to facilitate efficient collection and management of outcomes data.
Administrative and Program Support - Support Spine Research Program leadership and research staff with study-related administrative activities and special projects.
- Coordinate research team meetings and assist with preparation of meeting materials and documentation.
- Assist with preparation of reports, presentations, abstracts, manuscripts, and program-related documents.
- Support management of study files, investigator documentation, and research program records.
- Assist with study finance tracking and other operational activities as assigned.
- Provide support for student, volunteer, and observer activities within the research program as appropriate.
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