Clinical Trial Research Monitor - Beat Childhood Cancer Research Consortium

Penn State University • University Park, PA

130d • $56,200 - $89,600

About The Position

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) is an international clinical research sponsor and acts as a Contract Research Organization (CRO) of a network of 50+ hospitals across the US and Canada that participate in BCC's investigator-initiated clinical trials. This job does require 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. It is important that the candidate have experience working with a team, multiple Principal Investigators, and Phase I/II clinical trial projects. The candidate must have strong verbal and written communication skills and be able to multi-task while fostering an environment of collaboration and teamwork.

Requirements

• Bachelor's Degree and 1+ years of relevant experience or an equivalent combination of education and experience.
• 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.
• Strong verbal and written communication skills.
• Ability to multi-task while fostering an environment of collaboration and teamwork.

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.
• 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.
• 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.

Benefits

• Salary range: $56,200.00 - $89,600.00
• Possibility of refunding for the limited-term position.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Educational Services
• Education Level: Bachelor's degree