University of Rochester · 1 day ago
Clinical Trials Proj Spec I B
Rochester, New York Metropolitan Area
Full-time
Onsite
Entry Level
$26.90/hr - $37.66/hr
1+ years expThe University of Rochester is dedicated to the values of equity and integrity, and they are seeking a Clinical Trials Project Specialist I B to support clinical research trials. The role involves assisting the clinical study team with regulatory document management, coordinating human subject research activities, and preparing for study meetings under the guidance of senior peers.
Health CareMedicalUniversities
Responsibilities
Supports all aspects of clinical research trials
Supports the clinical study team by assisting with collection, tracking, and review of study related regulatory documents from study sites and maintaining study files
Assists senior peers in supporting clinical trial sites
Helps prepare for various clinical study meetings involving both internal and external teams
Requests, tracks receipt of, and reviews regulatory documents
Requests and tracks updated documents when necessary
Collaborates with study team to ensure that study file content and format are consistent with Good Clinical Practice, applicable regulations, and Standard Operating Procedures
Reviews site revisions to informed consent, ensures site changes are acceptable and advises sites when study documents are ready for Institutional Review Board (IRB) submission
Assists sites with questions related to IRB submissions as needed, under direction of senior peers
Under direction of senior peers, develops draft informed consent documents
Drafts revisions to existing informed consent documents to reflect changes in study protocol when necessary
Assists senior peers in preparing for meetings
Drafts minutes for project team meetings under the close supervision, direction and review of study team lead
Demonstrates ability to prepare IRB submissions
Oversees and coordinates human subject research activities for single and multiple sites
Develops, implements, and evaluates recruitment strategies, information, data systems, and study management systems
Participates in the planning, development, and implementation of a study design, budgets, protocols, consent forms, processes, and policies, including multiple therapeutic areas
Participates in the development, review, and approval of case report forms and study specific procedure manuals and documents
Other duties as assigned
Qualification
Required
Bachelor's degree
1 year or relevant experience
Or equivalent combination of education and experience
Preferred
Clinical trials experience
Knowledge of Good Clinical Practice, protocol planning, implementation, coordination, evaluation, and reporting of clinical trials
Strong communication skills, interpersonal skills, attention to detail, and organization skills
Company
University of Rochester
The University of Rochester is a private research university located in Rochester, New York.
10001+ employees
H1B Sponsorship
University of Rochester has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (234)
2024 (126)
2023 (130)
2022 (106)
2021 (100)
2020 (92)
Funding
Current Stage
Late StageTotal Funding
$20.43MKey Investors
National Science FoundationUnitedHealthcareSociety to Improve Diagnosis in Medicine
2023-09-25Grant· $18M
2023-07-26Grant· $0.07M
2022-09-20Grant· $0.05M
Leadership Team
David Linehan
Chief Executive Officer
Recent News
2025-12-04
Company data provided by crunchbase