- UPMC (Pittsburgh, PA)
- …of oncology-focused trials at Hillman. These trials include institutional (investigator-initiated), multi-center cooperative group/National Clinical Trial Network ... study development and implementation assistance, submissions to the FDA, IRB processing, patient recruitment, study coordination, study-specific training, data… more
- University of Pennsylvania (Philadelphia, PA)
- …adverse events according to regulatory requirements. + Prepares all documents for IRB review including draft informed consents written for subject reading ... PPMC inpatient/cath lab cardiology nurses. + Support and train new research coordinator. + Review all new trials in the cath lab to help identify the challenges and… more
- University of Pennsylvania (Philadelphia, PA)
- …work as part of a team as well as independently + Knowledge of IRB and human research protection regulations required Position continuous upon funding. Job Location ... - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $74,500.00 - $104,809.00 Annual Rate Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to… more
- Actalent (Philadelphia, PA)
- …for study enrollment. + Manage informed consent processes and maintain compliance with IRB guidelines. + Report adverse events using CTCAE and ensure patient safety ... throughout the study. + Collaborate with research teams to ensure adherence to Good Clinical Practice (GCP) standards. Required Skills & Experience + Registered Nurse with a license in the Commonwealth of Pennsylvania. + At least 5 years of experience as a… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …trials and projects. + Ensures activities related to site qualification, IRB submission, site initiation, interim monitoring, site management activities, and ... close-out visits (performed on-site or remotely) are performed in compliance with the study-specific Clinical Monitoring Plan, Standard Operating Procedures, GCP, and applicable government regulations and guidelines. + Responsible for monitoring and trial… more
- Carnegie Mellon University (Pittsburgh, PA)
- …supports research compliance requirements on supported awards includinghuman subjects ( IRB ) and animal (IACUC) protocols, clinical trials, export controls, andother ... compliance related requirements. + Program support may include supporting calls for projects by creating online submissionforms, assisting with coordinating web presence for specific programs, and point ofcontact for submissions, initial reviews and… more
- University of Pennsylvania (Philadelphia, PA)
- …regulatory documentation through the IRB , FDA and all applicable institutional regulatory review committees. In collaboration with clinical research teams ... and investigators he/she will prepare, and process all required regulatory documentation for NIH, pharmaceutical companies, contract research organizations (CROs), and the FDA, as well as, organize and maintain all regulatory affairs documentation/files as… more
- University of Pennsylvania (Philadelphia, PA)
- …Recruit, schedule and run research subjects; execute subject payments. + Assist with IRB prep and grant prep. + Order supplies and maintain study databases; maintain ... lab documentation for best practices, publications, update website, etc. + Document study procedures and maintain study documentation + Perform literature searches + Coordinate with internal and external researchers to organize project related activities in a… more
- University of Pennsylvania (Philadelphia, PA)
- …of robust data collection and quality‑control processes, supports grant and IRB activities, and contributes to dissemination of study findings. By overseeing ... data storage, database integrity, and QA workflows, the coordinator strengthens research reproducibility and accelerates project milestones. Job Description Job Responsibilities + Research Data Management & Quality Assurance + Research Operations &… more
- University of Pennsylvania (Philadelphia, PA)
- …also include: transporting specimens, submission of study documents to all applicable institutional committees (eg, IRB , CTSRMC, IBC, CHPS) for initial approval, ... to the PI or medical team in order to obtain guidance or assistance. + Review all clinical and laboratory data and adverse events, reporting in real-time to the… more