Clinical Research Monitor

Job Description:

The Department of Neurology, BIOS Clinical Trials Coordinating Center (CTCC) is seeking a Clinical Research Monitor (CRM) who will 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 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, support of the clinical trial research goals of the BIOS Clinical Trials Coordinating Center’s (CTCC) by monitoring numerous centers’ specified trial cycle metrics, and 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 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.
• Traveling for monitoring visits expected to be minimal and in line with remote-based approach.
• Other duties as assigned.

Additional knowledge, skills, and abilities

• Knowledge of medical terminology and human subject research is necessary.
• Experience with local and/or single IRB policies and submissions.
• Proficient in Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, and Teams.
• Proficient with SharePoint, collaborating and co-authoring of documents.
• Experience with REDCap preferred.
• Possess the ability to learn new software programs such as electronic data capture software, eIRB, and project management software, which will be taught on the job.

Minimum Qualifications

• Bachelor’s Degree in related field.
• Minimum 5 years of experience with clinical trials/medical research required.
• Thorough knowledge of ICH GCP and FDA guidelines.
• Experience using Electronic Data Capturing (EDC) systems.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond HS Diploma/Graduation Equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• BA/BS in medical research or scientific discipline, health care, or other appropriate discipline.
• Certified Clinical Research Associate (CCRA) credentialing.
• Experience with quality assurance or clinical trial auditing/monitoring, and/or good clinical practice.
• Experience with REDCap preferred.

Classified Title: Sr. Compliance Monitoring Specialist
Job Posting Title (Working Title): Clinical Research Monitor
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $55,800 - $97,600 Annually (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