Clinical Trial Research Monitor - Beat Childhood Cancer Research Consortium

About the role

The Beat Childhood Cancer Research Consortium at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Monitor.

Responsibilities

• Ensure the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents.
• 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.
• Understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
• Maintain and monitor investigational sites as per ICH GCP guidelines and the BCC Study Monitoring Plan for each BCC study.
• Conduct monitoring visits, including Site Initiation, Site Monitoring, and Site Close Out, either onsite or remotely.
• Verify trial data accuracy and completeness, resolve CRF data and queries according to study timelines.
• Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled according to 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.

Requirements

• Bachelor's Degree
• 1+ years of relevant experience or an equivalent combination of education and experience

Qualifications

• Master's Degree preferred
• 1+ years of relevant experience or an equivalent combination of education and experience

Skills

• 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

Benefits

This is a limited-term position funded for one year from date of hire, with possibility of refunding. Salary range is $59,580.00 - $94,980.00. For more details, please refer to the Benefits Page.

Pay

$59,580.00 - $94,980.00

Schedule

Not specified