University of Cincinnati - Cincinnati, OH
posted 7 months ago
About the position
The University of Cincinnati (UC) is seeking a Clinical Research Professional to join the College of Medicine, specifically within the Cancer Programs. This role is pivotal in supporting the University’s mission of excellence in research and education. The Clinical Research Professional will primarily focus on regulatory affairs, ensuring that all necessary protocols and documentation are meticulously prepared and submitted in compliance with relevant regulations. The position is designed to oversee clinical studies from their inception through to the point of patient accrual, thereby playing a crucial role in the operational success of the University of Cincinnati Cancer Center. As a Start-Up Coordinator, the individual will be responsible for managing the entire lifecycle of clinical studies, which includes conducting feasibility assessments and scientific reviews. The role requires the completion of initial Institutional Review Board (IRB) submissions and the preparation of site-adapted Informed Consent Forms (ICFs) tailored to local requirements. Additionally, the coordinator will be tasked with collecting and completing essential regulatory documentation necessary for the start-up phase of clinical trials, coordinating contract and budget submissions, and providing ongoing status reports regarding the studies in the start-up process. Daily interactions with sponsors, Contract Research Organizations (CROs), and internal UC staff will be a significant part of the role, necessitating excellent communication skills and the ability to work collaboratively across various teams. The position also involves other related duties as assigned, contributing to the overall efficiency and effectiveness of the clinical research operations at UC.
Responsibilities
- Oversee a study from initial interest through opening to accrual at UC.
- Support feasibility and scientific review processes.
- Complete initial IRB submission.
- Assist in preparation of site adapted ICF according to local requirements.
- Collect and complete essential regulatory documentation for start-up.
- Coordinate contract and budget submissions.
- Provide ongoing status reports about studies in start-up process.
- Interact daily with sponsors, CROs, and internal UC staff.
- Perform other related duties as assigned.
Requirements
- Bachelor's degree in related discipline or equivalent education/experience.
- 1-3 years of relevant experience, ideally in an academic, clinical, or laboratory setting.
- Knowledge of medical and pharmaceutical terminology and concepts.
- Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines.
- Experience preparing various forms, documents, and reports related to clinical research.
- Experience preparing, reviewing, and understanding clinical research protocols and protocol amendments.
- Strong administrative and organization skills with the ability to prioritize assignments under pressure.
- Experience creating Informed Consent Documents that comply with HRPP/UC IRB policies and procedures.
- Proficient in standard word processing and data management software programs, including Word and Excel.
Nice-to-haves
- Experience in an academic or clinical setting in the area of clinical specialization.
- Excellent communication skills with sponsors, coworkers, and physicians.
- Experience developing and maintaining record management systems.
- Proven ability to analyze data and propose solutions to issues.
- Detail-oriented with a logical and methodological approach to problem solving.
Benefits
- Competitive salary range dependent on the candidate's experience.
- Comprehensive insurance plans including medical, dental, vision, and prescription coverage.
- Flexible spending accounts and an award-winning employee wellness program.
- Financial security via life and long-term disability insurance, accident and illness insurance, and retirement savings plans.
- Generous paid time off options including vacation, sick leave, annual holidays, and winter season days in addition to paid parental leave.
- Tuition remission available for employees and their eligible dependents.
- Discounts for on and off-campus activities and services.
