Clinical Trial Research Monitor - Beat Childhood Cancer Research Consortium

POSITION SPECIFICS

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.

Travel to BCC hospital sites for monitoring visits approximately every 4-6 weeks is required.

The ideal candidate will have a strong background in Clinical Trial Management, Human Subjects Research, and IND/IDE regulatory requirements. The candidate must have experience working with a team, multiple Principal Investigators, and Phase I/II clinical trial projects. Strong verbal and written communication skills and the ability to multi-task while fostering an environment of collaboration and teamwork are essential.

Approval of remote and hybrid work is not guaranteed regardless of work location. For additional information on remote work at Penn State, see Notice to Out of State Applicants.

• Build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure 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.
• Monitor investigational sites as per ICH GCP 5.18 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 and 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 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 a Professional or Intermediate Professional level depending on the candidate's education and experience.

Research Project Manager
- Professional:
Bachelor's Degree; no prior relevant work experience required; previous relevant work experience accepted in lieu of education; required certifications: none.

Research Project Manager
- Intermediate Professional:
Master's Degree; 1+ years of relevant experience or equivalent; required certifications: none.

This is a limited-term position funded for one year from date of hire, with possibility of refunding.

Penn State does not sponsor or take over sponsorship of a staff employment Visa. Applicants must be authorized to work in the U.S.

Employment will require successful completion of background check(s) in accordance with University policies.

This job requires that you operate a motor vehicle as 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.

The salary range for this position, including all possible grades, is $56,200.00 - $89,600.00.

Salary Structure
- Information on Penn State's salary structure.

Penn State provides a competitive benefits package for full-time employees designed to…