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.

-Experience working in a clinical setting or research setting.

-Familiar with medical terminology.

-Experience with systems, including Epic and OnCore.

-Familiar with GCP (Good Clinical Practice).

For consideration, please complete an application and include a cover letter, resume and the names and email addresses of three to five references.