Clinical Research Interns - Clinical Trials Office

The Pennsylvania State University; United States; On-site; USD 21,000 - 30,000; Part time

Job summary

The Pennsylvania State University is seeking a Research Team Assistant to support clinical and behavioral studies by recruiting and scheduling participants, conducting informed consent discussions, and maintaining participant databases.

You will assist with monitoring study activities to ensure compliance with protocols and regulatory policies, prepare documentation, and help with quality assurance audits. This internship offers 20-40 hours per week for 10-12 weeks.

Responsibilities

• 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

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

• 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.

CAMPUS 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, affirmative action 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. Penn State is committed to and accountable for advancing equity, respect, and belonging. We embrace individual uniqueness, as well as a culture of belonging that supports equity initiatives, leverages the educational and institutional benefits of inclusion in society, and provides opportunities for engagement intended to help all members of the community thrive. We value belonging as a core strength and an essential element of the university’s teaching, research, and service mission.

Our values are as follows; Integrity, Respect, Responsibility, Discovery, Excellence, and Community. We Are Penn State. One Community. Impacting Many.

Federal Contractors Labor Law Poster PA State Labor Law Poster Penn State Policies Copyright Information Hotlines There’s a reason Penn State consistently ranks among the top one percent of the world’s universities. Across 24 campuses, our 100,000 students and 40,000 faculty and staff know the real measure of success goes beyond the classroom – it’s the positive impact made on communities across the world. Our ideals stem from our origins as Pennsylvania’s sole land-grant institution, which allow us to continue to bring positive impact to humanity through our teaching, research, and engagement mission. And across the world is a community of Penn Staters – more than half a million strong – driven by that same spirit to serve our local and global communities. At Penn State, passion is met with collaboration in an environment that is rooted in shared pride for the accomplishments of our fellow students, faculty, staff, and alumni. Penn Staters cheer each other on to build a culture committed to service and engagement. Our University values represent our core ethical aspirations for all our daily activities and actions as students, faculty, staff, and volunteers at Penn State. Our values are as follows; Integrity, Respect, Responsibility, Discovery, Excellence, and Community. We Are Penn State. One Community. Impacting Many.