Clinical Research Coordinator I

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

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ESSENTIAL FUNCTIONS

• Assists with the administrative details required to conduct human subject research.
• Works under supervision to learn and apply the details of standard protocols, including inclusion and exclusion criteria, informed consent procedures, study activities, source documentation and case report form (CRFs) completion, and adverse event reporting.
• Maintains all logs, including system data entry, according to all pre-established Standard Operating Procedures (SOPs).
• Assists in entering research data into data collection forms and/or study databases.
• Practices continuous learning in accordance with Good Clinical Practice (GCP) standards and guidelines.
• Maintains requisite skills and completes mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
• Obtains and maintains various certifications applicable to the filed and/or assigned subject matters. Gains knowledge in medical research terminology.
• Gains and practices proficiency in specific research software needed to manage clinical research protocols.
• Keeps up to date with new developments in the field by reading related literature and studying relevant clinical standards.
• May present/share these educational findings with other team members.
• Participates in protocol-related training as required.
• Complies with Good Clinical Practice and other applicable regulations.
• Keeps current with all federal, state, sponsor, and institutional policies, laws, standard operating procedures, and guidelines.
• Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.

Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• High School diploma required
• Associate's degree preferred
• Or equivalent combination of education and experience

KNOWLEDGE, SKILLS AND ABILITIES

• Ability to understand and follow simple research protocols and procedures preferred
• Ability to adhere to applicable safety and/or infection control standards preferred
• Ability to understand and follow data integrity standards and processes preferred
• Strong interpersonal, communication, and organizational skills, and ability to work well in teams preferred
• Proficiency in Microsoft Office Suite (e.g. Word, Excel, and PowerPoint), email, and internet preferred

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Classes). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates for all persons consistent with our values and based on applicable law.