Clinical Trial Research Monitor - Beat Childhood Cancer Research Consortium

Penn State University•Tallahassee, FL

12d•$56,200 - $89,600•Hybrid

About The Position

The Beat Childhood Cancer Research Consortium (BCC) at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Monitor. The BCC is an international clinical research sponsor and acts as a Contract Research Organization (CRO) for a network of over 50 hospitals across the US and Canada that participate in BCC's investigator-initiated clinical trials. This role requires travel to BCC hospital sites for monitoring visits approximately every 4-6 weeks. The ideal candidate will possess a 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 is important. The candidate must demonstrate strong verbal and written communication skills and the ability to multitask while fostering an environment of collaboration and teamwork.

Requirements

Bachelor's Degree and 1+ years of relevant experience or an equivalent combination of education and experience.
Strong background in Clinical Trial Management.
Strong background in Human Subjects Research.
Strong background in IND/IDE regulatory requirements.
Experience working with a team.
Experience working with multiple Principal Investigators.
Experience with Phase I/II clinical trial projects.
Strong verbal and written communication skills.
Ability to multitask.
Ability to foster an environment of collaboration and teamwork.
Must operate a motor vehicle as part of job duties.
Valid US driver’s license.
Successful completion of a motor vehicle records check.
Successful completion of standard background checks.
Must be authorized to work in the U.S.

Nice To Haves

Additional education and/or experience required for higher level positions.

Responsibilities

Ensuring the rights and wellbeing of trial participants are protected.
Ensuring reported trial data are accurate, complete, and verifiable from source documents.
Serving as the primary contact between Investigational Sites and BCC Leadership.
Ensuring clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and BCC SOPs.
Building relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure efficient, expedited, and smooth management of clinical trials.
Fostering internal and external relationships to ensure focus on efficient, timely, and productive project delivery as per study requirements and timelines.
Understanding the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials in collaboration with Regulatory teammates.
Monitoring investigational sites as per ICH GCP §5.18 (Monitoring) and the BCC Study Monitoring Plan for each BCC study, including all monitoring visit types across all phases of a clinical trial (Site Initiation, Site Monitoring, and Site Close Out).
Ensuring safety issues are reported to BCC promptly.
Verifying trial data are accurate and complete, ensuring CRF data and queries are completed and resolved as per study timelines documented in the Study Monitoring Plan.
Ensuring all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Study Monitoring Plan and the Protocol.
Providing guidance to sites to help establish and/or enhance processes for data collection and data management.
Educating BCC enrolling sites staff concerning protocols, EDC, and regulatory requirements and expectations.