Clinical Research Coordinator II-Department of Neurosurgery

Classification Title: Clinical Research Coordinator II Classification Minimum Requirements: Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience. Job Description: Research Coordination * Coordinate clinical research studies and clinical trials in compliance with Good Clinical Practice (GCP) standards and other regulatory and legal requirements. * Screen and assist with the identification of research participants. * Obtain informed consent from study participants. * Schedule clinic visits and required testing for research participants. * Assist regulatory and research administration teams with preparation and management of IRB submissions. * Document investigational product (drug/device) accountability. * Create and maintain organized research study files and regulatory documentation. * Develop and manage research databases. * Perform accurate data entry and maintain study records. * Self-monitor and self-audit responsibilities. * Assist in the maintenance of ClinicalTrials.gov. * Develop case report forms (CRFs). * Trains junior coordinators and delegates (with supervisor approval) as appropriate. Clinical Data Collection and Outcomes Reporting * Collect and manage patient-reported outcomes (PROMs) and quality assurance data. * Track clinical outcomes for spine center programs and research projects. * Analyze data and prepare reports to measure program performance and effectiveness. * Develop and maintain dashboards and reporting tools to display outcomes data. * Serve as liaison for data-related projects between the clinic, referral teams, hospital partners, and other relevant teams. * Develop tools and processes to support quality control and institutional data tracking. Administrative Support * Support the Research Director and Spine Center leadership with data reporting and special projects. * Schedule and facilitate Comprehensive Spine Center meetings and assist with preparation of monthly meeting agendas and meeting coordination. * Coordinate student and volunteer shadowing opportunities. * Assist with drafting reports, presentations, manuscripts, and program documents. Expected Salary: $61,350-$69,700 Required Qualifications: Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience. Preferred: * Experience using Epic and/or OnCore * Prior experience coordinating clinical research studies in a clinical setting, preferably in orthopedics or spine * Familiarity with spine conditions and procedures (e.g., spinal fusion, disc herniation, spinal stenosis) * Experience with IRB submissions, regulatory documentation, and maintaining study regulatory binders * Experience with electronic data capture systems (e.g., REDCap or Medidata Rave) * Experience with patient recruitment, screening, and informed consent for clinical trials * Clinical research certification (e.g., CCRC through the Association of Clinical Research Professionals or CRC through the Society of Clinical Research Associates) preferred Special Instructions to Applicants: For consideration, please complete an application and include a cover letter, resume, and the names and email addresses of three to five references.

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