Clinical Trial Research Monitor– Beat Childhood Cancer Research Consortium

at  Penn State University

JOB DESCRIPTION AND POSITION REQUIREMENTS:

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.
For more information on BCC visit our website: Home | Beat Childhood Cancer (beatcc.org)
Job Duties & Responsibilities:

The Clinical Trial Research Monitor is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. This position is the primary contact between the Investigational Sites and BCC Leadership. Key responsibility of this position 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 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.

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.
This position will be filled at an Intermediate or Advanced Professional depending on the candidate’s education and experience. This position requires a Master’s Degree and 1+ years of relevant experience or an equivalent combination of education and experience. Additional education and/or experience required for higher level positions.
This is a limited-term position funded for one year from date of hire, with possibility of refunding.

The following clearances must be successfully completed for this position:

• Pennsylvania State Police Criminal Background Check

• Pennsylvania Child Abuse HistoryFederal Bureau of Investigation (FBI) Criminal Background Check

• The Pennsylvania State University is committed to and accountable for advancing diversity, equity, and inclusion in all of its forms. We embrace individual uniqueness, foster a culture of inclusive excellence that supports both broad and specific diversity initiatives, leverage the educational and institutional benefits of diversity, and engage all individuals to help them thrive. We value inclusive excellence as a core strength and an essential element of our public service mission.
  The salary range for this position, including all possible grades is:
  $61,800.00 - $102,300.00
  Salary Structure - additional information on Penn State’s job and salary structure.

• 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