Human Subject Research Coordinator I
Rochester, NY
Responsibilities
Appropriate Catergories of Patients Served by the Employee Include
Pediatric
18-65 yrs
OVer 65 yrs
Position Summary
The DET I is a position requiring a basic foundation in clinical research through assigned responsibilities in data management. Under the direction of the Principal Investigator (PI), Supervisor, Study Coordinator III (SC III), department program director, or designee, the DET I exhibits increased learned skills and flexibility in performing duties, and assumes responsibility for the data management of clinical research protocols.
Supervision/Direction Received
Director Clinical Trials Office – Clinical Operations; Clinical Trial Manager
Typical Duties
Managing the Study 45%
Independently performs chart review/pre-screening for eligibility and coordination of simple clinical research protocols.
Maintains all logs, including OnCore entry according to UR and department SOPs.
Manages and organizes case report forms, source documents and research records.
Conducts data collection activities according to established operational procedures and timelines.
Assists in the data management and reporting of adverse events.
Fully adheres to established procedures, policies, and standards in implementing clinical research protocols.
Adheres to continuous research quality improvement practices.
Maintains safety, environmental, and/or infection control standards throughout job duties.
Assists in entering research data into data collection forms and/or study databases.
Assists in conducting quality checks for data accuracy with data source records as assigned.
Exhibits increasingly sound judgment in planning/performing data entry and reporting of research protocols for optimal quality research.
Maintaining Study Continuity and Coordinating Logistics, Research Procedures, and Study Participants 40%
Participates in pre-screening activities for study participant eligibility, maintaining enrollment procedures according to the protocol.
Performs data collection activities according to established operational procedures and timelines.
Observes for deviations and takes action to minimize them. Reports deviations when they occur, addressing adverse events with supervision.
Shows increasing organizational skills to facilitate full adherence to timelines.
Continues to learn how to recognize and report logistical challenges in data collection and reporting to the research team, assisting in resolving challenges.
Assists in identifying and developing data collection tools. Assists the Study Coordinator in data tasks.
Performs quality checks for data accuracy, reports/follows-up with discrepancies.
Professional Development 15%
Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
Maintains CITI and Conflict of Interest (COI) certification and renewal as required.
Gains knowledge in medical research terminology.
Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols.
Participates in protocol-related training as required.
Duties as assigned
Machines/Equipment Used
Computer, Printer, Copier
Requirements
Education:
Bachelor’s degree (health-related field preferred).
Experience: No previous experience required; Or equivalent combination of education and experience e.g. an Associate’s degree and completion of 6 months in the Human Subject Research Coordinator Trainee program.
Mandatory CITI training prior to participating in any research-related procedures.
Competencies and Skills
Understands and follows simple research protocols and procedures.
Fully adheres to applicable safety and/or infection control standards.
Understands and follows data integrity standards and processes.
Strong interpersonal, communication (verbal and written), and organizational skills.
Highly collaborative, works well in teams.
Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet.
Fluent English language skills required (oral and written).
Note: An equivalent combination of education and experience, which provides proficiency in the areas of responsibility listed above, may be substituted for the above education and experience requirements.
The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion 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 status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 051 Cancer Center/Clin Trials Ofc