Clinical Trials Compliance Lead (Study Startup & Oversight)

Penn State University; Hershey (PA); On-site; USD 60,000 - 86,000; Full time

Benefits offered by this job

75% tuition discount

Competitive benefits package

Job summary

Penn State University in Hershey, PA seeks a Compliance Specialist to oversee regulatory and compliance aspects of a cancer clinical trials portfolio, ensuring GCP adherence, training, protocol compliance and timely reporting of adverse events.

The role includes study startup coordination, CDA execution, sponsor communications, and ensuring all documents are aligned for activation while coordinating with IRB, biosafety, contracts, and other PSCI committees.

Qualifications

• Bachelor's Degree and 1+ years of relevant experience; or an equivalent combination of education and experience.

Responsibilities

• Manage all regulatory and compliance aspects of a portfolio of cancer clinical trials, including ensuring protocol investigators and staff are fully certified and trained.
• Ensure compliance with good clinical practice and protocol follow-up, timely continuing reviews and reporting of adverse events.
• Act as a study startup coordinator for multiple new trials, including CDA execution and document alignment for activation.
• Serve as liaison among the PI, study team and stakeholders, manage training logs and required documentation.

Skills

Regulatory compliance

GCP adherence

IRB liaison

Education

Bachelor's Degree

1+ years of relevant experience

Job description

Penn State University in Hershey, PA seeks a Compliance Specialist to oversee regulatory and compliance aspects of a cancer clinical trials portfolio, ensuring GCP adherence, training, protocol compliance and timely reporting of adverse events.

The role includes study startup coordination, CDA execution, sponsor communications, and ensuring all documents are aligned for activation while coordinating with IRB, biosafety, contracts, and other PSCI committees.