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Description:

GENERAL PURPOSE: The Department of Medicine, Division of Pulmonary Critical Care, at The University of Rochester is seeking a full-time Human Subject Research Specialist, Level II, to coordinate human subject research activities. The division of Pulmonary Critical Care has a robust research portfolio that encompasses Pulmonary Arterial Hypertension, Lung Cancer Screening, Chronic Obstructive Pulmonary Disease, Sepsis, Air Pollution and Inhaled Toxins, Airway Inflammation and Lung Function in Asthma, Oscillometry in Airway Disease, Pulmonary Fibrosis and Lung Scarring, Pulmonary Embolism and Hypoxemic Respiratory Failure. This individual would primarily support Clinical Trials that are focused on Airway Inflammation and Lung Function in Asthma and will be expected to meet regularly with Principal Investigators for oversight of trial recruitment, data management, interactions with subjects and communication with regulators (e.g. CRO, IRB). The coordinator will also provide cross-coverage of other trials in the Division with oversight from the Divisional Clinical Research Manager” With minimum direction and latitude for independent judgement, this individual will be responsible for human subject research activities, including the development, implementation and evaluation of recruitment strategies, information, data systems and study management systems; development, review and approval of case report forms (CRFs) and study-specific procedure manuals and documents. This position may direct activities of subordinate staff and also train research coordinators and other staff on activities associated with conducting human subject research specific to study protocols. JOB DUTIES AND RESPONSIBILITIES: Oversees and coordinates human subject research activities for multiple clinical trials, with an emphasis on those that are focused on Airway Inflammation and Lung Function in Asthma • Participates in the planning, development and implementation of study design, budgets, protocols, consent forms, processes and policies • Receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials to immediate team members and relevant others • Develops, implements and evaluates recruitment strategies, information and data systems and study management systems for assigned studies • Facilitates eligibility screening and study recruitment activities, including study timelines and schedules appointments and study visits • Conducts visits to ensure research participant adherence with protocol requirements. Data Collection, Management and Maintenance • Participates in the development, review and approval of case report forms (CRFs) and study-specific procedure manuals and documents • Performs data collection and uses required data systems for tracking study progression, monitoring and reporting on deliverables, quality and safety tracking, according to protocol requirements and established operational procedures and timelines • Maintains relevant study logs, through sponsors related, and University related systems, including OnCore, according to UR and department Standard Operating Procedures (SOPs). Regulatory, Quality and Compliance • Participate with the IRB to address any issues with the on-going studies, prepare and submit annual reviews, prepare and submit study amendments. • 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. • 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 Communication • Represents sites, providers, study team, patients, study participants and the University with regard to the coordination of human subjects studies • Prepares for, participates in and serves as a liaison for sponsor monitoring visits. Develops good working relationship with sponsors to foster a positive research environment and attend study Investigator/Coordinator meetings as required • Develops, monitors and maintain working relationships, positive communications among the Principal Investigator, research staff, study sites, sponsor and regulatory agencies, with regard to the coordination of human subject studies. Training • Trains on study specific protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements. • Trains research coordinators and other staff on activities associated with conducting human subject research specific to study protocols • Directs the activities of subordinate staff to gather, compile and analyze study information Professional Development • Demonstrates accountability for continuous learning in accordance with Good Clinical Practice (GCP) standards and guidelines. • Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. • Maintains CITI and Conflict of Interest (COI) certification and renewal as required. • Maintains proficiency in UR-specific research software, such as ClickIRB and OnCore, needed to manage clinical research. • Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards • Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines • Participates in protocol-related training as required Other duties as assigned.

Skills:

Clinical research, Clinical trial, Regulatory, Patient recruitment

Top Skills Details:

Clinical research,Clinical trial,Regulatory,Patient recruitment

Additional Skills & Qualifications:

• Bachelor’s degree required. • 3 years of experience in human subject research coordination required

Experience Level:

Intermediate Level

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