Compliance Specialist - Intermediate Professional

- Manage all regulatory and compliance aspects of a portfolio of cancer clinical trials, including ensuring that the protocol investigators and staff are fully certified and trained for the trials, ensuring that they are complying with good clinical practice and following the protocol, that continuing reviews and reportable new information are performed on time, and adverse events are promptly and accurately reported. Also manage study amendments, action letters and other changes to the protocol. The primary difference between this position and Compliance specialist-professional is that the number and complexity of active trials being managed will be greater.

- Act as a study startup coordinator for multiple new trials, from the process of ensuring that CDA's are appropriately executed between sponsors and investigators/Penn state, all the way up to ensuring that congruence of all documents is perfect and the study ready for activation. This involves very frequent communication with sponsor, investigators, COM offices of budget, legal, contracts, IRB and related committees (e.g. biosafety, radiation safety), as well as PSCI specific committees including protocol scientific review committee and data safety committee. The primary difference between this position and Compliance specialist-professional is that the number and complexity of active trials being managed will be greater, and will include some work in the phase I arena.

- Serve as a liaison among the PI, study team (investigators and research staff) and other stakeholders including people from other departments involved in the study but are not part of the official study team (e.g. radiology, pathology et al.). Manage training logs and other documentation required.

- Participation in disease team meetings including preparation of reports/slides for meetings. Compile information from meetings, particularly action items, and communicate them to stakeholders.

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.

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