Clinical Trial Research Monitor - Beat… at Penn State… · College…

Summary: The Pennsylvania State University is hiring a Clinical Trial Research Monitor for the Beat Childhood Cancer Research Consortium at the College of Medicine. This role involves ensuring the rights and wellbeing of trial participants are protected and that trial data is accurate and compliant with regulatory requirements, while also building relationships with various stakeholders in the clinical trial process. Responsibilities: - Build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials - Foster internal and external relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines - In collaboration with Regulatory teammates, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials - Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the BCC Study Monitoring Plan for each BCC study. This includes all monitoring visit types across all phases of a clinical trial including Site Initiation, Site Monitoring and Site Close Out. Visits may be conducted either onsite or remote as needed - Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are reported to BCC promptly - Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Study Monitoring Plan - Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Study Monitoring Plan and the Protocol - Provide guidance to sites to help establish and/or enhance processes for data collection and data management. Educate BCC enrolling sites staff concerning protocols, EDC and regulatory requirements and expectations Required Qualifications: - Bachelor's Degree - 1+ years of relevant experience or an equivalent combination of education and experience accepted - Strong background in Clinical Trial Management - Experience in Human Subjects Research - Knowledge of IND/IDE regulatory requirements - Experience working with a team and multiple Principal Investigators - Experience with Phase I/II clinical trial projects - Strong verbal and written communication skills - Ability to multi-task while fostering an environment of collaboration and teamwork - Valid US driver's license and successful completion of a motor vehicle records check - Successful completion of background check(s) in accordance with University policies Preferred Qualifications: - Master's Degree - Previous relevant work experience accepted in lieu of education Required Skills: Clinical Trial Management, Human Subjects Research, IND/IDE regulatory requirements, ICH GCP guidelines, Regulatory requirements compliance, Clinical trial monitoring, Adverse Event reporting, Source data verification, Clinical trial protocol compliance, Electronic Data Capture (EDC), Study drug accountability Benefits: Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being., Comprehensive medical, dental, and vision coverage, Robust retirement plans, Substantial paid time off which includes holidays, vacation and sick time, Generous 75% tuition discount, available to employees as well as eligible spouses and children