Clinical Trial Research Monitor

4 weeks ago


Hershey, Pennsylvania, United States Penn State University Full time
Job Summary:

The Clinical Trial Research Monitor will be 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.

Key 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. 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.

Requirements:
  • A Master'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 and ability to multi-task while fostering an environment of collaboration and teamwork.

Additional Information:
  • 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 History, and Federal Bureau of Investigation (FBI) Criminal Background Check.


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