Human Sub Research Spec II

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Job Location (Full Address):

265 Crittenden Blvd, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400104 Neurology Movement Disorders

Work Shift:

UR - Day (United States of America)

Range:

UR URG 108 H

Compensation Range:

$24.91 - $34.87

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.

Responsibilities:

GENERAL PURPOSE:
With considerable latitude for independent judgment, coordinates all aspects of assigned human subject research studies for the department of Neurology Movement Disorders division.

Typically, responsible for the successful coordination of complex interventional or large multi-site clinical drug trials. Receives delegation of study tasks from multiple Principal Investigators and works as an integral part of the research team. May provide mentorship to Human Subject Research Specialist I.

ESSENTIAL FUNCTIONS

Study Visits:

Recruits, consents, schedules, and conducts research subject visits for complex studies (i.e., industry-sponsored clinical drug trials involving greater risk to subjects) in accordance with study protocol, coordinating these visits with the Principal Investigator.

• Develops, implements, and evaluates subject recruitment and retention strategies. 
• Consents subjects to assigned research studies
• Schedules and facilitates visits, performing study related procedures as outlined in protocol
• Draws blood and performs testing such as ECG, timed mobility tests, and cognitive function tests, depending on the protocol
• Coordinates and documents dispensing and returning of study drugs/materials

Study Visits:

Recruits, consents, schedules, and conducts research subject visits for complex studies (i.e., industry-sponsored clinical drug trials involving greater risk to subjects) in accordance with study protocol, coordinating these visits with the Principal Investigator.

• Resolves questions and concerns received from study subjects, triaging to Principal Investigator as necessary
• 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 coordinating and monitoring financial data for budget and variance reporting, documentation, and reporting deliverables
• Understands, implements, and provides training on most recent study protocol (e.g., amended protocol), procedures, documentation, and use of study materials to subjects and team members as appropriate. Ensures compliance, following up and communicating as needed. 

Mentoring:

Mentors and trains Human Subject Research Specialist I (HSRS I) on activities related to conducting human subject research.

• Provides study-specific training, oversight, and back-up support.
• Trains on federal, state, sponsor, and/or institutional regulations, policies, and practices related to human subject research.
• Mentors on activities specific to conducting research for complex studies.
• Completes annual performance evaluations/reviews for HSRS I.

Regulatory Oversight:

Oversees and manages the regulatory details for multiple assigned research studies.

• Creates, modifies, organizes, and maintains study documentation for the regulatory file
• Manages and submits study applications, amendments, and continuing reviews for IRB approval
• Ensures compliance with all applicable regulatory and institutional requirements and standards
• Ensures the integrity and security of all study documents at all times
• Initiates, monitors, and ensures that regulatory activities are standardized across studies. Implements immediate and appropriate corrective action when inconsistency of activities is identified

Liaison:

Serves as the liaison between