Job Description
General Purpose
Seeking a full-time Human Subject Research Specialist, Level II, to coordinate human subject research activities.
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
Additional Skills & Qualifications - Bachelor’s degree required.
- 3 years of experience in human subject research coordination required
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
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The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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Job Tags
Full time, Contract work, Immediate start,