Senior Human Subject Research Specialist

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Job Location (Full Address):

220 Hutchison Rd, Rochester, New York, United States of America, 14620

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400094 Neurology - NMD M & D

Work Shift:

UR - Day (United States of America)

Range:

UR URG 110 H

Compensation Range:

$29.33 - $41.06

Responsibilities:

Under general direction and with considerable latitude to exercise independent judgement, serves as senior research specialist for the Neuromuscular Disease division. Manages and oversees the operations of assigned divisional clinical research programs. Manages and coordinates all aspects of complex multi-center and international studies and projects. This includes oversight of inventory, preparation, calibration and cleaning processes of remote research equipment, coordinating and tracking of equipment shipments, monitoring of equipment inventory and initiating and coordinating equipment purchases. Creates patient facing study materials e.g. manuals, and standard of operation manuals for study set up. Provides support to the Principal Investigator, Research Administration, and research study staff working as an integral part of the study team. Responsible for the coordination and oversight of regulatory compliance for assigned Neuromuscular Disease division research program. Plans, directs, monitors and coordinates all phases of human subject research, which may include multi-site, community-based research or multiple therapeutic areas. Manages, designs, implements and evaluates study changes. Develops, manages, and coordinates with sites outside the University of Rochester with the Empire State ALS Alliance. Directs the planning, implementation, coordination, operation and evaluation of divisional procedures required to ensure quality study execution. Creates recruitment, retention and outreach planning for the Neuromuscular Disease division clinical research programs to grow and enhance clinical research operations.

ESSENTIAL FUNCTIONS

• Oversees human subject research activities for single or multiple sites. Develops, implements, and evaluates study subject requirement strategies, information and data systems and study management systems. Creates, plans, develops, implements, and manages study design, budgets, protocols, consent forms, processes and policies, including multiple therapeutic areas. Creates, develops, reviews, and approves case report forms and study-specific procedures, manuals and documents. Directs the development and execution of research activities for multicenter funded national and international research studies. 
• Liaises with Data management center at sites external to URMC, resolve queries of multiple sites, edit the study database, and analyze data. Serves as primary contact with data managers to obtain relevant subject data such as enrollment numbers and adverse events
• Represents sites, providers, study team, patients, study participants and the University to establish, develop, oversee, monitor, and maintain working relationships, positive communications, and effective results. Responsible for supporting the contacts and relationships between and among Principal Investigators (PI), research staff, study sites, and sponsoring and regulatory agencies.  Manages compliance with regulatory and institutional requirements and designs systems and processes to monitor and document routing audits for divisional studies. Serves as the liaison to sponsor study monitors.  Coordinates and attends monitor meetings according to protocol.  Prepares for and participates in schedules sponsor monitoring visits.  Builds relationships with sponsors, advocacy groups, community and institution to assist with strategic growth of the division’s research.
• Manages and mentors research coordinators of various levels. Develops, delivers and monitors efficacy of training on the conducting of human subject research in accordance with approved protocols and in compliance with the Good Clinical Practices (GCPs), including training on policies and practices used by sponsors for the purpose of meeting regulatory requirements.  Trains and oversees other divisional human subjects research coordinators on protocol, procedures, new test/surveys, and other institutional and sponsor requirements.
• Designs, develops, implements, monitors, and manages systems and methods to ensure quality, safety, efficiency, and consistency in the processing of data. Reviews study progress, including data, finances, timeframes, documentation, and reporting deliverables. Manages, implements, and monitors systems for tracking and evaluating study progression. Tracks and monitors metrics associated with study start up, recruitment, enrollment, protocol violations, adverse events, amendments, regulatory filings, etc. for the division. 
• Develops, documents, and implements Standard Operating Procedures (SOPs) at all sites and ensures adherence to established SOPs. Writes and maintains protocols and associated documentation such as enrollment forms, eligibility checklists, adverse event reporting forms and case report forms.  Ensures integrity of all study data collected.  Serves as the liaison to sponsor study monitors.  Coordinates and attends monitor meetings according to protocol.  Prepares for and participates in schedules sponsor monitoring visits. 
• Oversees and coordinates with investigators on grant preparation and submission of grant content assembly for study manuals, procedural manuals, and manuals of operation. Establishes study-specific processes for distribution of study funds. Manages expenses, equipment, and study materials. Prepares and monitors operating and financial reports and documents for review and analysis.  Coordinates and monitors financial data and spend categories for budget and variance reporting, and for compliance with all institutional requirements for adequate system controls.  Reports variances to research administrator.
• 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.
• Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 5 years of experience in human subject coordination required
• Master’s in Health Science Related Field preferred
• Or equivalent combination of education and experience
• Experience as a Phlebotomist preferred
• Experience in human subject research coordination for Neurologic Disorders preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of word processing and data analysis software required

LICENSES AND CERTIFICATIONS

• SOCRA - Certification In Clinical Research upon hire preferred
• Association of Clinical Research Professionals (ACRP) upon hire preferred

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