- University of Pennsylvania (Philadelphia, PA)
- …multiple clinical trials. Primary responsibilities will include the following clinical, regulatory and budgetary duties: 1. Clinical: Recruit and assess research ... charts into online databases, data entry and management 2. Regulatory - preparation, submission and monitoring of human subject's protocols,...Will supervise the execution of the trial with the staff to ensure adherence to the protocol is followed… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …other Data Managers, Programmers, Biostatisticians, Clinical Operations, Medical Directors, and Regulatory staff to meet project deliverables and timelines for ... . **Job Description** As part of the Medical and Scientific Affairs group, an integral delivery unit within the Global Clinical … more
- PNC (Pittsburgh, PA)
- …management, line of business, finance, risk management, internal audit, legal, and regulatory affairs partners across PNC. Your work will contribute directly ... + Works with internal teams including business lines, finance, risk management and regulatory affairs . + Executes business strategy and coordinates responses and… more
- University of Pennsylvania (Philadelphia, PA)
- …guidelines. Scheduling clinical and research visits, interacting with clinicians and staff to schedule and oversee research testing, assist or coordinate specimen ... of study related activities including but not limited to regulatory submissions, data entry, and regulatory compliance...PennChart, LabVantage). May be responsible for orientation/mentoring of new staff and act as resource to current staff… more
- University of Pennsylvania (Philadelphia, PA)
- …Description Summary This entry-level position will support the faculty and clinical research staff of the Department of Medicine in the preparation for, conduct of, ... requires significant dedication and resilience to acquire and apply regulatory knowledge with the duty to protect research patient...to protect research patient safety and data integrity. The staff member will complete all tasks delegated by the… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the… more
- University of Pennsylvania (Philadelphia, PA)
- …will also require an accurate, complex-level documentation for internal and regulatory reporting following Good Documentation Practices. Demonstrated expertise as an ... to ensure data is accurate, logical, and consistent with institutional and regulatory reporting requirements. The PDE Manager, with minimal direction, is expected to… more
- UPMC (Butler, PA)
- …of Radiation Therapy (https://mycareer.upmc.com/the-lasting-impact-of-radiation-therapy/) . Responsibilities: + Regulatory Affairs Management: Champions and ... and provides meaningful insight and feedback to ensure compliance with all regulatory groups. Facilitate CPR recertification for staff . Risk Master reporting… more
- University of Pennsylvania (Philadelphia, PA)
- …Works directly with study physicians, research director and other research staff . Major duties include screen/enroll patients, conduct follow-up assessments, data ... Works directly with study physicians, research director and other research staff . Performs screening visits, consenting of participants, processing and shipping of… more
- University of Pennsylvania (Philadelphia, PA)
- …Surgery Program Manager will manage clinical research coordinators and associated research staff within Department of Surgery at The Hospital of the University of ... County Hospital (CCH). The Program Manager will assess the workload of the staff and properly delegate responsibilities and provide guidance as needed. This includes… more