Compliance Specialist - Intermediate Professional

The Pennsylvania State University; Hershey (PA); On-site; USD 70,000 - 110,000; Full time

Job summary

The Pennsylvania State University’s Cancer Institute in Hershey, PA is seeking a Compliance Specialist to ensure regulatory compliance across a portfolio of cancer clinical trials, including GCP adherence, sponsor communications, and timely adverse event reporting.

Responsibilities include study startup coordination, document congruence, training log management, and liaison among investigators, sponsors, and PSCI/IRB committees.

Qualifications

• Must manage regulatory and compliance aspects of cancer clinical trials, ensuring staff are trained and compliant with GCP and protocol.
• Coordinate amendments, reports, and adverse event reporting; support trial activation and management across multiple trials.

Responsibilities

• Manage regulatory and compliance aspects of a portfolio of cancer clinical trials, ensuring protocol investigators are trained and compliant.
• Act as study startup coordinator for multiple new trials, ensuring CDA execution and document congruence for activation.
• Serve as liaison among PI, study team, sponsors, and PSCI/IRB committees; manage training logs and documentation.
• Participate in disease team meetings and prepare/action items communications for stakeholders.

Skills

Regulatory compliance

Clinical trials management

GCP training

Study startup coordination

Stakeholder communication

Job description

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.

POSITION SPECIFICS

The Cancer Institute at the Penn State College in Hershey, PA is seeking a Compliance Specialist. This position involves ensuring that the quality of research in the PSCI CTO is pristine in terms of compliance with all regulations including those from our PSCI IRB, other IRB's, FDA, sponsor's obligations etc. This applies both to active ongoing clinical trials and also to the development/startup of new clinical trials in the office. The latter (startup of new trials) are absolutely necessary to increasing clinical trials activity and help for our patients; however this process is fraught with potential error and risk management without leadership from high quality compliance specialist.

MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS

acceptedRequiredCertifications:None

• - 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.

SALARY & BENEFITS

Salary Structure - Information on Penn State's salary structure

Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being. In addition to comprehensive medical, dental, and vision coverage, employees enjoy robust retirement plans and substantial paid time off which includes holidays, vacation and sick time. One of the standout benefits is the generous 75% tuition discount, available to employees as well as eligible spouses and children. For more detailed information, please visit our Benefits Page.

CAMPU sc SECURITY CRIME STATISTICS

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.

EEO IS THE LAW

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.