Research Project Manager 3 – Public Health Sciences

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JOB DESCRIPTION AND POSITION REQUIREMENTS:

The Penn State College of Medicine, Department of Public Health, in Hershey PA is seeking a full-time research project manager/scientific coordinator for a new five-year grant, titled “The Biostatistics Research Center (BRC) for the Impaired Awareness of Hypoglycemia (IAH) Consortium.” The grant is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The IAH Consortium will conduct a randomized clinical trial across 9 clinical centers (5 in the US, 2 in the United Kingdom, and 2 in Australia) to investigate the heterogeneity in response from using continuous glucose monitors. The BRC will (1) collaborate on the development and conduct of clinical trials and ancillary studies, and lead statistical analyses, (2) lead the consortium in developing measures of self-reported IAH, (3) house a central laboratory, (4) lead the Consortium in stakeholder engagement, (5) develop data management and website processes, (6) maintain regulatory compliance, and (7) provide communication and project management support.

The project/scientific will perform the following duties:

• lead the operational aspects of protocol design, such as determining eligibility, establishing the visit structure, and assist in finalizing the technical and logistical components of the protocol.
• manage the BRC protocol team and lead the weekly BRC protocol team and clinical center (CC) coordinator meetings
• set the timelines for:
  • creating study materials such as CRFs, handouts/reference cards, data validation system, manuals of procedures (MOP), visit scheduler, and randomization modules
  • acquiring study drugs and devices
  • defining and configuring labels and data flow for bio-specimens
  • directing the Data Management and Research Computing teams in developing the accrual, quality control, and participant status reports
  • training and certification of clinical site staff
• oversee data audits
• receive and seek resolutions to questions or problems from the IAH Consortium
• create study reports for the BRC and safety and quality control reports for the DSMB
• serve as the primary BRC contact for CC coordinators
• assist in developing and implementing the plan for dissemination of research results
• collaborate in writing, reviewing, and editing manuscript drafts
• participate in Steering Committee meetings, and attend subcommittee and Data and Safety Monitoring Board (DSMB) meetings as necessary

TYPICAL EDUCATION & EXPERIENCE

4+ years related experience in clinical research

Master’s of Science Degree or higher

Or an equivalent combination of education and experience

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
• Federal 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.  

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

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