After extensive training, the trainee will provide assistance to the Human Subjects Research Coordinators I & II, Senior Human Research Coordinators and Principal Investigators to conduct industry-sponsored and investigator-initiated clinical trials.
Typical activities include assisting with:
- Recruitment of participants and explaining study information to participants
- Collection, organization and verification of study data and entering data into an electronic data capture system
- Completion and maintenance of electronic case report forms
- Collection and processing of study specimens
- Maintenance of study documentation.
Will follow university research guidelines for human subjects research during the COVID-19 pandemic. Demonstrates the ICARE values of integrity, inclusion, compassion, accountability, respect and excellence.
Reports to and is given direction by the CTSI Senior Clinical Workforce Program Manager and is accountable to Human Subjects Research Coordinators and the Principal Investigator in assigned departments according to specific service line activities.
- Assists with the administrative details required to initiate and conduct human subject research, including receiving, distributing and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and relevant others. 20%
- Tracks regulatory and other documents, such as consent forms and CRFs, and ensures these are complete, accurate and available for review. 20%
- Learns and applies the details of the protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, source documentation and case report form (CRFs) completion and adverse event reporting. 15%
- Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria, processing biospecimens and conducting telephone interviews to screen potential study candidates. 15%
- Tracks research participant adherence with protocol requirements, such as taking of medications, proper use of device and/or other interventional activities, to document adverse events and report to senior study staff, PI, Institutional Review Board (IRB), Sponsor and/or any other required recipients or entities. 15%
- Tracks and documents the dispensing and returning of study materials, such as study drugs and devices. 5%
- Keeps current with all federal, state, sponsor and institutional policies and laws, SOPs and guidelines. Manages and evaluates resulting study changes. Demonstrates accountability for continuous learning in accordance with GCPs. Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies. 5%
- Other duties as assigned 5%
- Associate’s degree or higher required without experience or an equivalent combination of experience and education.
- Excellent organizational, interpersonal and communication skills, including written communication.
- Experience as a phlebotomist.
- Knowledge of word processing and data analysis software.
The University of Rochester is committed to fostering, cultivating and preserving a culture of diversity and inclusion. The University believes that a diverse workforce and inclusive workplace culture enhances the performance of our organization and our ability to fulfill our important missions. The University is committed to fostering and supporting a workplace culture inclusive of people regardless of their race, ethnicity, national origin, gender, gender identity, sexual orientation, socio-economic status, marital status, age, physical abilities, political affiliation, religious beliefs or any other non-merit fact, so that all employees feel included, equally valued and supported.
Apply online and look for Job ID 228957 and Job ID 228958.