Clinical Research Interns - Clinical Trials Office

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POSITION SPECIFICS

The Penn State College of Medicine, Clinical Trials Office, in Hershey, PA is seeking Clinical Research Interns.

This position is for students who have successfully completed the Penn State University course HHD497 Special Topics: Clinical Research Practice to gain practical, real-world experience in clinical research.

• Participate in internship educational experiences

• Recruit and schedule participants for research visits

• Engage in informed consent discussions with research participants

• Maintain participant database(s)

• Assist with the monitoring of study activities to ensure compliance with protocols and with relevant local, federal, and state regulatory and institutional polices.

• Maintains required records of study activity including case report forms and essential documents.

• Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.

• Oversees participant enrollment to ensure that informed consent is properly obtained and documented.

• Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies. Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

• Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.

• Prepares study-related documentation such as protocol worksheets, adverse event reports, institutional review board documents, and progress reports. Submit applicable amendments, continuations, and renewals to the Institutional Review Board

• Organize study materials, conduct data collection, monitor incoming data for accuracy

• Communicates with investigators regarding participant research visit activities, including laboratory findings for reconciliation

• Monitor the safety and confidentiality of the project and its participants

• Troubleshoot for technical problems and maintain the integrity of the project protocol

An intern can expect to work 20-40 hours per week for 10-12 weeks.

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