合规监控专员 (神经学)
Compliance Monitoring Specialist (Neurology)
神经病学系正在寻找一位合规监控专员，为医学院的BIOS部门工作。该职位通过基于风险的远程监控和合规监督，确保多中心临床试验数据的质量、准确性和完整性，支持BIOS CTCC推进神经科学研究的使命。合规监控专员负责根据既定政策和程序对临床研究试验进行合规监控审查。
具体职责与任务
- 与研究项目人员安排合规监控访问。
- 开发特定于方案的表格。
- 根据临床方案审查研究和医疗记录以确保合规性。
- 准备合规审查结果的书面摘要。
- 与主要研究者和数据支持人员会面，讨论合规结果。
- 必要时跟进审查结果。
- 在OnCore中为所有方案审查维护日程和审查信息。
- 协助研究团队准备外部审计。
- 根据需要参与非计划的内部审查和合规监控审查，以及附属机构的审查。
- 与研究项目人员安排合规监控访问，以监控数据完整性研究。
- 生成问题并跟进不符合规定的问题。
- 生成监控摘要报告并传达这些发现。
- 以研究法规和审查方案及病例报告模板的形式，为受监控的试验提供支持。
- 在适当的时候协助工作人员制定合规审查观察结果的纠正措施。
- 协助新研究员工的合规培训；可能需要做演讲以支持这一工作。
- 通过审查新研究以确保质量保证和一般内容，并对新研究进行编码，参与各分委员会。
- 准备各委员会对研究的审查。
- 参加并参与每月会议。
- 协助开发和维护研究手册中指定区域网站上的标准操作程序（SOP）。
- 进行定期的合规审查。
- 其他指派的任务。
除上述职责外
- 使用已建立的工具和检查清单进行常规监控访问（远程和现场），并记录发现。
- 协助准备研究和文件以应对内部和外部审计和检查。
- 跟踪并跟进已识别的问题
查看英文原文
The Department of Neurology is seeking a Compliance Monitoring Specialistfor the BIOS division in the School of Medicine. This position ensures quality, accuracy, and integrity of multi-center clinical trial data through risk-based remote monitoring and compliance oversight, supporting BIOS CTCC’s mission to advance neurological research. The Compliance Monitoring Specialist is responsible for conducting compliance monitoring reviews of clinical research trials in keeping with established policies and procedures.
Specific Duties & Responsibilities
- Schedule compliance monitoring visits with research study staff.
- Develop protocol specific forms.
- Review research and medical records against clinical protocols for compliance.
- Prepare written summary of compliance review results.
- Meet with principal investigators and data support staff to review compliance results.
- Follow-up on results, as necessary.
- Maintain scheduling and review information in OnCore for all protocol reviews.
- Help study staff to prepare for external audits.
- Participate in unscheduled internal reviews and compliance monitoring reviews at affiliate institutions as needed.
- Schedule compliance monitoring visits with research study staff to monitor data integrity studies.
- Generate queries and conduct follow-up for non-compliance issues.
- Generate monitoring summary reports and communicate these findings.
- Provide support for monitored trials in the form of research into regulations and review of protocols and Case report templates for protocol staff.
- Assist staff in developing corrective actions for compliance review observations when appropriate.
- Assist in training new research staff regarding research compliance; may make presentations to support this effort.
- Participate on subcommittees by reviewing new studies for quality assurance and general content, and coding new studies.
- Prepare reviews of studies by various committees.
- Attend and participate in monthly meetings.
- Assist in the development and maintenance of SOPs for the research manual on assigned areas website as needed.
- Perform periodic compliance reviews.
- Other duties as assigned.
In addition to the duties above
- Conducts routine monitoring visits (remote and on-site) using established tools and checklists and documents findings.
- Assists with preparing studies and documentation for internal and external audits and inspections.
- Tracks and follows up on identified findings to support timely resolution and compliance improvement.
- Supports maintenance of monitoring trackers, logs, and reporting tools to ensure audit readiness.
Minimum Qualifications
· Bachelor’s Degree.
· Three years of related experience with clinical trials/medical research.
· Eligible for certification by a professional organization in human subjects research.
· Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
- Bachelor’s Degree in Life Sciences, Health Care or a related field.
- Certification in human subjects research.
Technical Skills & Expected Level of Proficiency
- Clinical Documentation Review - Intermediate
- Data Analysis - Intermediate
- Documentation - Intermediate
- Project Management - Intermediate
- Regulatory Compliance - Intermediate
- SOP Development - Intermediate
- Training and Development - Intermediate
The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.
Classified Title: Compliance Monitoring Specialist
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $49,200 - $86,200 Annually ($55,800 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
FLSA Status: Exempt
Location: Remote
Department name: SOM Neuro BIOS
Personnel area: School of Medicine
Originally posted on Himalayas