Job Information
University of Rochester Human Sub Research Spec II in Rochester, New York
GENERAL PURPOSE:
Human Subject Research Specialist II is a mid-level clinical research coordinator responsible for assisting in the planning, coordinating, implementing, monitoring and evaluating human subject research activities, within the division of Infectious Diseases. They will work closely with study team members and other staff/faculty/study sites to ensure study coordination in aggregation with maintaining study participant safety and adherence to approved protocols, regulatory guidelines and operational procedures.
JOB DUTIES AND RESPONSIBILITIES:
Administers all protocol required study procedures on subjects
Facilitate daily coordination of clinical trial activities for the infectious disease research clinic including but not limited to disease of respiratory pathogens such as COVID19, Influenza and RSV.
Initiates, monitors and ensures that all protocol activities are standardized across study sites.
Includes performing procedures including but not limited to nasal swabs, nasal washes, venipuncture, urine collection.
Reviews and interprets study guidelines for next steps necessary for the processing and/or shipment of samples
Implements immediate and appropriate corrective action when inconsistency of activities is identified.
Ensures compliance in the reporting of subject serious adverse events (SAE) and filing of these in a timely manner to sponsors and IRBs.
Coordinates Enrollment of Participants
Independently manages and coordinates enrollment of participant, including the following tasks:
Performs chart review/pre-screening for eligibility of potential study participants
Develops, implements and evaluates recruitment strategies
Collects the necessary data to initiate the study visit; Enrolls and consents study subjects, confirming eligibility, coordinating subject visits
Manages and organized case report forms, source documents and research records.
Accurately enters research data into data collection form and/or study databases
Conducts quality checks for data accuracy as needed
Maintains Database and Study Specific Research Logs
Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression.
Assists with the design of study data entry forms as needed.
Collect and maintain subject data in designated subject databases and managed regulatory binders for assigned studies.
Participate in entering the study data into appropriate EDCs (Electronic Data Capture) systems, ensuring all data meets study-specific requirements as needed.
Regulatory and Compliance
Develops, implements, and monitors systems and methods to ensure quality, safety, efficiency, and consistency in the processing of human subject research data
Ensures compliance with all applicable regulatory and institutional requirements and standards.
Maintains regulatory records and necessary correspondence
Works under the direction of the Manager of Quality Assurance to assist with audits and responding to audit findings as well as assisting with study sponsor monitoring visits and correspondence.
Ensures the integrity and security of study data at all times.
Initiates, monitors, and ensures that all protocol activities are standardized across study sites.
Complies with Good Clinical Practice (GCP) and Federal Regulations
Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines.
Demonstrates accountability for continuous learning following GCP guidelines.
Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs. Implements and monitors resulting study changes.
Professional Development
Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies
Maintains CITI and other training/certifications as required
Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols
Other duties as assigned
QUALIFICATIONS:
Bachelor’s degree required.
3 years of experience in human subject research coordination;
or an equivalent combination of education and experience required.
Experience as Human Subject Coordinator I preferred.
Word processing and data analysis software reuqired.
Professional Research Coordinator certification (SoCRA or ACRP) preferred.
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.
Pay Range
Pay Range: $50,752 - $71,053 Annually
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Apply for Job
Careers
Sign In
New User
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening:
Schedule: