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.

$61,350-$69,700

• 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

Application must be submitted by 11:55 p.m. (ET) of the posting end date.