Clinical Trials Compliance & Start-up Lead

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

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.