Human Subject Res Coordinator II, Neuromuscular
Rochester, NY
GENERAL PURPOSE:
Coordinates the activities associated with human subject research.
RESPONSIBILITIES:
Project Management and Coordination:
Oversees and coordinates investigators with grant preparation and submission of grant content assembly for study manuals, procedural manuals, manuals of operation.
Prepares study manuals as needed to ensure uniformity of subject assessment and data collection in collaboration with the investigators. Participates in the planning, development and implementation of study design, protocols, consent forms, processes and policies that may include multiple therapeutic areas. Participates in the development, review and approval of case report forms (CRFs) and study-specific procedure manuals and documents.
Understands and provides training to other staff on protocols, procedures, documentation, and use of study materials to participants and team members as appropriate. Ensures compliance and follows up and communicates as needed. Directs the activities of other staff and relevant others to gather, compile and analyze study information.
Serves as the liaison to the sponsor’s Study Monitor. Sets up and attends monitor meetings according to protocol. Prepares for and participates in scheduled Sponsor monitoring visits. Interacts with the sponsor’s team, including the Project Manager, to resolve queries from clinical research visits. Interfaces with collaborating investigators, sponsors, and drug companies. Represents sites, providers, study team, patients, study participants and the University to develop, monitor and maintain working relationships, positive communications and effective results with regard to the coordination of human subject studies. Responsible for supporting the contacts and relationships between and among Principal Investigator, research staff, study sites, sponsoring and regulatory agencies.
Schedules, and conducts visits for research subjects, coordinating these visits with the Principal Investigator. Resolves questions and concerns received from study subjects, triaging to the Principal Investigator as necessary.
Performs testing such as timed mobility tests, sensory testing, questionnaire administration, image analysis, (Meissner corpuscles), electrophysiologic assessments, interrater reliability studies of image analysis. Performs microscopy and data analysis of epidermal nerve fibers depending on the protocol.
Obtains relevant medical records, develops, implements and evaluates recruitment strategies, information and data systems, as well as study management systems.
Regulatory Compliance:
Develops surveys (redcap preferably) database.
Prepares and submits study protocols for IRB approval and with the assistance of the investigator. Submits continuing annual reviews to the IRB. Prepares and maintains all IRB submissions. Ensures all regulatory requirements are met and documented. Updates information on Federal Clinical Trials web site.
Responsible for FDA compliance, maintenance and progress reports for Investigational New Drug approvals.
Ensures compliance with all applicable regulatory and institutional requirements and standards and collaborates with RSRB and central IRBs to ensure regulatory compliance. Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. Reviews study progress, including data, finances, documentation and reporting deliverables. Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression.
Develops and submits progress reports to RSRB and FDA as appropriate.
Supervises study visits to ensure protocol is adhered to including subject evaluations, sample collections and ensuring the completeness and accuracy of data collection.
Reports adverse events as needed.
Collaborates with data managers to obtain relevant subject data (such as enrollment numbers and adverse events) for reporting to regulatory and funding agencies.
Coordinates and documents dispensing and returning of study drugs/materials.
Keeps current with study specific training, institutional certifications/policies, industry standards and best practices.
Ensures the integrity and security of all study data at all times. Initiates, monitors and ensures that all protocol activities are standardized across study sites. Implements immediate and appropriate corrective action when inconsistency of activities is identified.
Multi-Site Study Coordination:
Oversees and coordinates site visits, audits, and human subject research activities among the various sites.
Monitors fibroblast and DNA samples amongst the various sites.
Coordinates tissue samples (skin biopsies) and data analysis among each site.
Financial and Budgetary:
Work with research administrators in providing cost estimates for portions of the study protocol.
Coordinates and monitors financial data for budget and variance reporting, and for compliance with all institutional requirements for adequate system controls.
Collaborates with research administrator to develop budgets for grant proposals.
Monitors spending categories related to research projects and reports variances to research administrator.
Reviews invoices for clinical trials for accuracy.
Other duties as assigned
QUALIFICATIONS:
Bachelor’s degree with major coursework in an appropriate health, social, or technical field required
3 years related experience in human subject research coordination; or an equivalent combination of education and relevant experience required.
Experience as Human Subject Research Coordinator I preferred
Knowledge of word processing and data analysis software required
Professional Research Coordinator Certification (i.e., 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.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range
Pay Range: $51,810 - $72,534 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.
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