- Johns Hopkins University (Baltimore, MD)
- …materials for IRB such as Change in Research applications, Continuing Review or other Regulatory submissions when needed. + Prepares for and participates in ... errors in database when necessary and reports adverse events as needed to IRB . Writes responses to audit reports with input from the Principal Investigator. +… more
- ThermoFisher Scientific (Bethesda, MD)
- …information. + Reports suspected non-compliance to relevant site staff. + Ensures that IRB approval is obtained prior to study initiation and IRB requirements ... are met throughout the study. + Promotes the company and builds a positive relationship with patients to ensure retention. + Attends site initiation meetings and all other relevant meetings to receive training on protocol. + May be required to call patients,… more
- Johns Hopkins University (Baltimore, MD)
- …data in approved systems. + Serve as liaison between study team and IRB for routine administrative matters. + Prepare routine reports related to study accrual, ... study trends, efficiency-related issues. + Contact participants to confirm, schedule, and retain. + Other duties as assigned. **Minimum Qualifications** + High school diploma or graduation equivalent. + One year of related experience. + Additional education… more
- University of Maryland, Baltimore (Baltimore, MD)
- …with recruiting and screening subjects for research studies according to IRB approved protocols. * Assist in verifying participant eligibility; obtains consent ... and enrollment; and assures accurate demographic information for follow-up. * Assist with data analysis and interpretation, and the development of statistical reports of study data using descriptive statistics using SAS, STATA, and SPSS statistical software.… more
- Johns Hopkins University (Baltimore, MD)
- …and calculations using a computerized database, word processing and spreadsheet software; review data input for accuracy and completeness. + Actively communicate and ... program-related reports and papers. + Prepare study documents for IRB submission, as needed. + Follow all written and...Prepare weekly report of work hours and activities for review by supervisor. + Carry out duties and responsibilities… more
- Johns Hopkins University (Baltimore, MD)
- …and calculations using a computerized database, word processing and spreadsheet software, review data input for accuracy and completeness. + Actively communicate and ... program-related reports and papers. + Prepare study documents for IRB submission, as needed. + Organize and file patient...Prepare weekly report of work hours and activities for review by supervisor. + Other duties as assigned. **Minimum… more
- Johns Hopkins University (Baltimore, MD)
- …and communicate with principal investigator on research protocols and programming, including IRB and regulatory issues. + Tracking of study visits and completion of ... study activities. + Oversight remuneration and remuneration tracking. + Conduct qualitative and quantitative data analysis. + Guide continuous quality improvement initiatives as part of study implementation and monitoring. + Participate in study meetings. +… more
- Guidehouse (Bethesda, MD)
- …compliance with NIH and FDA guidelines. + Support study teams in navigating IRB , radiation safety, and other review processes. + Maintain regulatory ... documentation, track approvals, and manage protocol lifecycle activities. + Liaise with internal and external stakeholders to establish CTAs, MTAs, and Certificates of Confidentiality. + Provide regulatory guidance, SOP development, and training on GCP and… more
- Johns Hopkins University (Baltimore, MD)
- …implementation. + Write and submit applications, amendments, annual renewals, etc. to the IRB and other regulatory agencies as needed. + Write study protocols and ... protocols, and ensure the study team is advised and appropriately trained. + Review consent procedures and study protocol with research subjects and study partners.… more
- University of Maryland, Baltimore (Baltimore, MD)
- …with recruiting and screening subjects for research studies according to IRB -approved protocols. * Assist in verifying participant eligibility; obtains consent and ... enrollment; and assures accurate demographic information for follow-up. * Assist with data analysis and interpretation, and the development of statistical reports of study data using descriptive statistics using SAS, STATA, and SPSS statistical software.… more