University of Rochester
Overview
Manager, Clinical Research – University of Rochester The University of Rochester is committed to Meliora — Ever Better. We value equity, leadership, integrity, openness, respect, and accountability. This role supports human subjects research in the URMC Department of Psychiatry, including recruitment, enrollment, follow-up, supervision of staff, and coordination of lab activities related to youth mental health research. Job Location
601 Elmwood Ave, Rochester, New York, United States of America, 14642 Position Details
Job Type: Full time Department: 400626 Psychiatry M&D Research Work Shift: UR - Day (United States of America) Scheduled Weekly Hours: 40 Compensation Range: $70,197.00 - $105,295.00 Responsibilities
GENERAL PURPOSE
Dr. Sheftall’s lab in the Dept. of Psychiatry, URMC, conducts and supervises human subjects research from recruitment to follow-up, interacting with research participants, and supervising post-baccalaureate Human Subject Research Coordinators and undergraduate students. May train new staff on federal, state, sponsor and institutional regulations related to human subject research. Will enroll patients and participate in community outreach. Provides high‑level support, oversight, training, and coordination for all lab activities. Essential Functions
Participant recruitment, enrollment, and retention: Oversees, coordinates and conducts human subject research activities for single or multiple sites. Recruits and enrolls participants. Follows up with study participants regarding assessments and communications, including protocol deviations. Supervisory Duties
Trains new research staff and student employees on activities related to human subject research per study protocols and GCP guidelines. Directs staff to gather, compile, and analyze study information. Manages study-related administrative and human resources tasks and coordinates study activities and personnel. Provides feedback for annual reviews and supports staff development plans as needed. Data Management
Implements systems to ensure quality, safety, efficiency, and consistency in processing human subject research data. Reviews study progress, data, documentation, and reporting deliverables. Designs and maintains procedures for tracking study progression. Ensures adherence to research standards, regulatory guidelines, and approved procedures. Ensures data collection from participating families follows SOPs and can generate summary data for funding agencies; completes data exports and updates documentation accordingly. Regulatory
Maintains ongoing compliance with Good Clinical Practice guidelines. Keeps current with industry standards and implements study changes as needed. Performs study coordination from protocol development to close-out according to regulatory and sponsor guidelines; maintains study integrity. Maintains IRBs and assists with URMC quality improvement audits; submits regulatory/sponsor reporting. Administrative
Orders materials for team projects, facilitates hiring and onboarding of lab staff, coordinates with departments to ensure readiness of new hires, manages software and essential forms, and supports recruitment and communications within the lab. Minimum Education & Experience
Bachelor's degree required 4 years of experience or equivalent combination of education and experience Experience as Human Subject Research Coordinator 1 preferred Knowledge, Skills And Abilities
Adherence to safety and infection control standards (Required) Ability to manage complex research protocols and competing priorities (Required) Strong interpersonal, organizational, and time management skills (Required) Highly collaborative with strong managerial skills (Required) Ability to build collaboration among research team members, staff, participants, and families; tact, empathy, and clear communication (Required) Self-motivation and sound decision-making skills (Required) Proficiency in MS Office (Word, Excel, Teams, PowerPoint), email, internet, Zoom (Required) Ability to write and edit SOPs and function as a liaison for Dr. Sheftall at local and national levels (Required) Ability to assess current protocols and suggest efficiency improvements (Required) Grant and manuscript writing/editing preferred Knowledge of GCP, RCR, IRB processes, safety standards, OSHA guidelines; regulatory compliance preferred Experience with mental health research preferred Proficiency in medical terminology and clinical research processes and regulatory guidelines (Preferred) Licenses and Certifications
CITI certification preferred CCRP – Certified Clinical Research Professional within 1 year of hire required SOCRA – Certification in Clinical Research required within 1 year of hire The University of Rochester is committed to fostering an inclusive and welcoming culture and to non-discrimination in employment. This includes protections based on age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, sex, sexual orientation, citizenship status, or other protected characteristics as required by law.
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Manager, Clinical Research – University of Rochester The University of Rochester is committed to Meliora — Ever Better. We value equity, leadership, integrity, openness, respect, and accountability. This role supports human subjects research in the URMC Department of Psychiatry, including recruitment, enrollment, follow-up, supervision of staff, and coordination of lab activities related to youth mental health research. Job Location
601 Elmwood Ave, Rochester, New York, United States of America, 14642 Position Details
Job Type: Full time Department: 400626 Psychiatry M&D Research Work Shift: UR - Day (United States of America) Scheduled Weekly Hours: 40 Compensation Range: $70,197.00 - $105,295.00 Responsibilities
GENERAL PURPOSE
Dr. Sheftall’s lab in the Dept. of Psychiatry, URMC, conducts and supervises human subjects research from recruitment to follow-up, interacting with research participants, and supervising post-baccalaureate Human Subject Research Coordinators and undergraduate students. May train new staff on federal, state, sponsor and institutional regulations related to human subject research. Will enroll patients and participate in community outreach. Provides high‑level support, oversight, training, and coordination for all lab activities. Essential Functions
Participant recruitment, enrollment, and retention: Oversees, coordinates and conducts human subject research activities for single or multiple sites. Recruits and enrolls participants. Follows up with study participants regarding assessments and communications, including protocol deviations. Supervisory Duties
Trains new research staff and student employees on activities related to human subject research per study protocols and GCP guidelines. Directs staff to gather, compile, and analyze study information. Manages study-related administrative and human resources tasks and coordinates study activities and personnel. Provides feedback for annual reviews and supports staff development plans as needed. Data Management
Implements systems to ensure quality, safety, efficiency, and consistency in processing human subject research data. Reviews study progress, data, documentation, and reporting deliverables. Designs and maintains procedures for tracking study progression. Ensures adherence to research standards, regulatory guidelines, and approved procedures. Ensures data collection from participating families follows SOPs and can generate summary data for funding agencies; completes data exports and updates documentation accordingly. Regulatory
Maintains ongoing compliance with Good Clinical Practice guidelines. Keeps current with industry standards and implements study changes as needed. Performs study coordination from protocol development to close-out according to regulatory and sponsor guidelines; maintains study integrity. Maintains IRBs and assists with URMC quality improvement audits; submits regulatory/sponsor reporting. Administrative
Orders materials for team projects, facilitates hiring and onboarding of lab staff, coordinates with departments to ensure readiness of new hires, manages software and essential forms, and supports recruitment and communications within the lab. Minimum Education & Experience
Bachelor's degree required 4 years of experience or equivalent combination of education and experience Experience as Human Subject Research Coordinator 1 preferred Knowledge, Skills And Abilities
Adherence to safety and infection control standards (Required) Ability to manage complex research protocols and competing priorities (Required) Strong interpersonal, organizational, and time management skills (Required) Highly collaborative with strong managerial skills (Required) Ability to build collaboration among research team members, staff, participants, and families; tact, empathy, and clear communication (Required) Self-motivation and sound decision-making skills (Required) Proficiency in MS Office (Word, Excel, Teams, PowerPoint), email, internet, Zoom (Required) Ability to write and edit SOPs and function as a liaison for Dr. Sheftall at local and national levels (Required) Ability to assess current protocols and suggest efficiency improvements (Required) Grant and manuscript writing/editing preferred Knowledge of GCP, RCR, IRB processes, safety standards, OSHA guidelines; regulatory compliance preferred Experience with mental health research preferred Proficiency in medical terminology and clinical research processes and regulatory guidelines (Preferred) Licenses and Certifications
CITI certification preferred CCRP – Certified Clinical Research Professional within 1 year of hire required SOCRA – Certification in Clinical Research required within 1 year of hire The University of Rochester is committed to fostering an inclusive and welcoming culture and to non-discrimination in employment. This includes protections based on age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, sex, sexual orientation, citizenship status, or other protected characteristics as required by law.
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