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The Department of Neurology is seeking a Sr. Compliance Monitoring Specialist for the BIOS Clinical Trials Coordinating Center (CTCC) to take the lead on compliance monitoring of predominantly large, multi-centered, clinical trials in keeping with established BIOS CTCC policies and procedures and GCP. The Sr. Compliance Monitoring Specialist will ensure quality, accuracy and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials through utilization of a risk-based, remote monitoring approach. In collaboration with clinical trial teams across the country, the position will support the research goals of the CTCC by monitoring multiple centers’ specified trial cycle metrics, protocol fidelity, and oversee local, institutional and federally required regulatory compliance across the network of collaborators.
Specific Duties & Responsibilities
Manage site and study progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
Participate in risk assessments by reviewing new studies for quality assurance and general content.
Develop standard and protocol specific forms and trial specific monitoring plans based on risk assessment.
Ensure the collection and maintenance of required essential documents and ensure these documents are delivered to the Trial Master File.
Assist in training new research staff regarding research compliance, including presentations sessions.
Generate queries and conduct follow-up for non-compliance issues. Generate monitoring summary reports and communicate these findings to investigators, research staff and Safety Monitoring Committee.
Verify that informed consent is obtained before each subject's participation in the trial. Verify that source documents, other trial records and CRFs are accurate, complete, and legible and that CRF entries reflect the source.
Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and take appropriate action designed to prevent recurrence of the detected deviations.
Determine whether adverse events are appropriately reported within the time periods required by GCP, the protocol, the Ethic Committees (IRB/IEC), sponsor and the applicable regulatory requirement(s).
Schedule compliance monitoring visits with research study staff to evaluate the quality and integrity of site practices and ensure GCP compliance and escalate quality issues as appropriate.
Assist staff in developing corrective actions for compliance review observations when appropriate.
Help study staff prepare for external audits. Participate in unscheduled internal reviews and compliance monitoring reviews at affiliate institutions on an as needed basis.
Educate principal investigators, clinical sites and/or individual coordinators regarding remote monitoring and remote data entry through presentations.
Traveling for monitoring visits expected to be minimal and in line with remote-based approach.
Other duties as assigned.
In addition to the duties above Manages site and study progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution.
Develops standard and protocol-specific forms and trial-specific monitoring plans based on risk assessment.
Verifies informed consent, source documents, trial records, and CRFs for accuracy, completeness, and consistency with source documentation.
Schedules compliance monitoring visits, communicates protocol and regulatory deviations, and escalates quality issues as appropriate.
Assists study staff with corrective actions and preparation for external audits and participates in internal compliance reviews as needed.
Minimum Qualifications Bachelor’s Degree.
Five years of related experience with clinical trials/medical research.
Thorough knowledge of ICH GCP and FDA guidelines.
Experience using electronic data capturing systems.
Strong attention to detail in clinical trial data, source document, and regulatory compliance review.
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 related field.
Certification in human subjects research.
Certified Clinical Research Associate (CCRA) credentialing.
Experience with quality assurance or clinical trial auditing/monitoring, and/or good clinical practice.
Experience with REDCap, SharePoint, and eIRB systems.
Experience with quality assurance or clinical trial auditing/monitoring, and/or good clinical practice preferred.
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: Sr. Compliance Monitoring Specialist Role/Level/Range: ACRP/04/MD Starting Salary Range: $57,195 - $100,040 Annually ($78,620 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