Clinical Research Coordinator II-Department of Neurosurgery
About The Position
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.
Requirements
- Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Nice To Haves
- 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
Responsibilities
- 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.
- 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1-10 employees
