Clinical Research Interns - Clinical Trials Office

Clinical Research InternThe 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.Responsibilities include:Participate in internship educational experiencesRecruit and schedule participants for research visitsEngage in informed consent discussions with research participantsMaintain 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 policies.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 BoardOrganize study materials, conduct data collection, monitor incoming data for accuracyCommunicates with investigators regarding participant research visit activities, including laboratory findings for reconciliationMonitor the safety and confidentiality of the project and its participantsTroubleshoot for technical problems and maintain the integrity of the project protocolAn intern can expect to work 20-40 hours per week for 10-12 weeks.