Research - Laboratory/Non-Laboratory, Staff/Administrative
The Sr. Compliance Monitoring Specialist will support the Brain Injury Outcomes Services (BIOS) Research Program and Clinical Trials Unit, which manages multi-center, 20+ million dollar federally funded clinical trials and multiple site-specific pharmaceutical sponsored trials. Provide support to the Division leadership. In collaboration with the Division of Brain Injury Outcomes (BIOS) leadership the Sr. Compliance Monitoring Specialist will take the lead on compliance monitoring of predominantly large, multi-centered, clinical trials in keeping with established BIOS 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..
Note: This position does not provide visa sponsorship.
Coordinate multiple Monitoring Plan Programs of the Division of BIOS
Manage site and study progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
Participate on 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 written 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 all adverse events (AEs) 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 in order to evaluate the quality and integrity of site practices to ensure GCP compliance and escalate any quality issues as appropriate.
Assist staff in developing corrective actions for compliance review observations when appropriate.
Help study staff to 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.
Other duties as assigned.
BA/BS in medical research or scientific discipline, health care related or other appropriate discipline preferred.
Must be eligible for certification by professional organization in the area of human subjects' research.
Certified Clinical Research Associate (CCRA) credentialing is preferred.
Minimum 5 years of experience with clinical trials/medical research required.
Thorough knowledge of ICH GCP and FDA guidelines.
Experience with quality assurance or clinical trial auditing/monitoring, and/or good clinical practice preferred. Experience using Electronic Data Capturing (EDC) systems.
Ability to work independently and exercise judgment necessary.
Excellent written and interpersonal communication skills and the ability to build effective relationships both internally and with trial center staff.
Knowledge of medical terminology and human subject research necessary.
Strong organizational, IT and administration skills with attention to detail.
The candidate must be proficient in Microsoft Excel and Word.
Traveling for monitoring visits expected to be minimal and in line with remote-based approach.
Classified Title: Sr. Compliance Monitoring Specialist Working Title: Clinical Research Monitor (CRM) Role/Level/Range: ACRP/04/MD Starting Salary Range: $52,495 - $72,210; commensurate with experience Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003520-SOM Neuro BIOS Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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