- Sumitomo Pharma (Harrisburg, PA)
- …and innovative trial protocols. + Oversee clinical trial execution, ensuring quality , patient safety, and compliance with GCP standards. + Develop and ... of the clinical programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory... study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with… more
- Penn Medicine (Radnor, PA)
- …Ensures staff are compliant with clinical competencies and mandatory trainings. + Regulatory Compliance : + Assists the practice or clinical leadership ... with clinical competencies and mandatory trainings. + Regulatory Compliance : + Assists the practice or...practice or clinical leadership with appropriate staffing, compliance (TJC CMS, DOH, OSHA), and continuous quality… more
- University of Pennsylvania (Philadelphia, PA)
- …protocol. Show vigilance in patient safety, protocol compliance and data quality . + Communicate clinical trial patient activity to the investigational drug ... University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards. The Clinical Research Coordinator (CRC)...The CRC will demonstrate vigilance in patient safety, protocol compliance , and data quality , and will participate… more
- Fresenius Medical Center (Dallas, PA)
- …all regulatory and FMS policy requirements. Ensure provision of quality patient care while maintaining cost-effective clinical operations in accordance ... with all legal, compliance , and regulatory requirements and programs. Adheres to all requirements of...and local laws and regulations. + Ensures all FMS Clinical Quality policies and procedures are communicated… more
- University of Pennsylvania (Philadelphia, PA)
- …activities including but not limited to regulatory submissions, data entry, and regulatory compliance visits. + Assure compliance with the protocol and ... be responsible for accurate data collection and overseeing the quality of the clinical trial data and...The CRC will demonstrate vigilance in patient safety, protocol compliance , and data quality , and will participate… more
- Pfizer (Collegeville, PA)
- …Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards. + Provide ... this position will interact directly with Clinical (Clinicians), Clinical Pharmacology, Statistical Programming, Data Management, Regulatory Strategy and… more
- University of Pennsylvania (Philadelphia, PA)
- …relating to the University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is an integral and ... and/or CROs. + Show vigilance in patient safety, protocol compliance , and data quality . + Adhere to...CVs and medical licenses, record of IRB certification and compliance ). + Resolve regulatory related queries with… more
- Pfizer (Collegeville, PA)
- …on assigned projects. Ensure that all statistics activities are conducted in compliance with relevant regulatory requirements and Pfizer standards. + Develop ... and business experience providing an understanding of the processes associated with clinical , regulatory and marketing operations. + Capability to provide… more
- Merck (North Wales, PA)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance , Regulatory Compliance , Scientific Leadership, Scientific… more
- Penn Medicine (Philadelphia, PA)
- …collaboratively with the Practice Manager to ensure compliance with Regulatory , Infection Control, Human Resource, Quality and Safety, Patient Satisfaction ... assessing the clinical care team to ensure quality , compliance with governmental agencies and patient... projects. Participates in strategic and operational planning. Maintains regulatory compliance (TJC, CMS, DOH, OSHA) Maintains… more