Clinical Trial Research Monitor - Beat Childhood Cancer Research Consortium

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.

This position will be filled at an Professional, Intermediate Professional depending on the candidate's education and experience. This position requires a Bachelor'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. 

This job requires that you operate a motor vehicle as a part of your job 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 check(s) in accordance with University polices. 

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. 

Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act and the Pennsylvania Act of 1988, Penn State publishes a combined Annual Security and Annual Fire Safety Report (ASR). The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters. The ASR is available for review here.

Penn State is an equal opportunity employer and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you are unable to use our online application process due to an impairment or disability, please contact 814-865-1473.

Federal Contractors Labor Law Poster

PA State Labor Law Poster

Penn State Policies

Copyright Information

Hotlines