Clinical Trial Research Monitor - Beat Childhood Cancer Research Consortium

Overview

Clinical Trial Research Monitor - Beat Childhood Cancer Research Consortium

The Beat Childhood Cancer Research Consortium at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Monitor. The Beat Childhood Cancer Research Consortium (BCC) operates as an international clinical research sponsor and acts as a Contract Research Organization (CRO) for a network of 50+ hospitals across the US and Canada that participate in BCC's investigator-initiated clinical trials.

This position requires travel to BCC hospital sites for monitoring visits approximately every 4-6 weeks.

The ideal candidate will have a strong background in Clinical Trial Management, Human Subjects Research, and IND/IDE regulatory requirements. Experience working with a team, multiple Principal Investigators, and Phase I/II clinical trial projects is important. The candidate should have strong verbal and written communication skills and be able to multi-task while fostering collaboration and teamwork.

For more information on BCC visit our website:
Beat Childhood Cancer (beatcc.org).

The Clinical Trial Research Monitor is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and that reported trial data are accurate, complete, and verifiable from source documents. This position is the primary contact between Investigational Sites and BCC Leadership. A key responsibility is ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and BCC SOPs.

• Build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure 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 onsite or remotely 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.

This position will be filled at an Advanced or Senior Professional depending on the candidate's education and experience. Requirements include a Bachelor's Degree and 3+ years of relevant experience or an equivalent combination of education and experience. An Advanced Degree or Certification is preferred.

This is a limited-term position funded for one year from date of hire, with possibility of renewal.

This job requires operating a motor vehicle as part of the duties. A valid US driver’s license and successful completion of a motor vehicle records check will be required in addition to standard background checks.

Employment will require successful completion of background checks in accordance with University policies.

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