- University of Pennsylvania (Philadelphia, PA)
- …functions independently with minimal supervision on complex protocols that are Investigator Initiated. The Regulatory Affairs Specialist C authors and conducts ... regulatory assessments of core documents (protocols, Informed Consents, investigator brochure, etc), and is responsible for leading and...requirements of the position, as well as internal and market factors and grade profile. Job Location - City,… more
- University of Pennsylvania (Philadelphia, PA)
- …set-up and execute clinical trials. May be required to speak at investigator meetings or site initiation visits for investigator -initiated trials ("IITs") ... and adverse events, reporting in real-time to the Principal Investigator (PI) for assessment and review, and communicate with...and in alignment with salary ranges based on external market data for the job's level. Internal organization and… more
- University of Pennsylvania (Philadelphia, PA)
- …cell biology and/or immunology to work in collaboration with the Principal Investigator , students, residents, and/or graduate students to study the immune response ... scientific progress in the lab in conjunction with the Principal Investigator . Training and/or expertise in computational biology, including single-cell sequencing… more
- University of Pennsylvania (Philadelphia, PA)
- …performed, reporting adverse events and ensuring review and appropriate follow-up by investigator , monitoring patient care and treatment side effects in concert with ... with design, set-up and execute studies. Be responsible for writing investigator -initiated IND/IDE clinical trials in collaboration with faculty supervisor. Speak at… more
- University of Pennsylvania (Philadelphia, PA)
- …requirements, and (2) meet required obligations to patients/subjects, Principal Investigator (PI), study team and Sponsor/CRO. This position will report ... contribute to study-related meetings, including but not limited to Investigator Meetings, Site Initiation Visits, Intermediate Monitoring Visits, Close-out Visits,… more
- Organon & Co. (Plymouth Meeting, PA)
- …2.5 and labeling for regulatory submissions, contribute the authoring of Investigator Brochures, IND subsections, briefing books, submission modules, responses to ... efficiency of the overall program development plans and enables fastest to market opportunities. + Represent the Clinical Pharmacology function or serve as subject… more
- University of Pennsylvania (Philadelphia, PA)
- …Affairs Start-Up Specialist is expected to oversee the development of investigator -initiated research protocols, the development and submission of FDA IND ... as, to provide direct regulatory/compliance guidance and oversight of investigator -initiated trials and investigator -initiated multi-site trials. Qualifications:… more
- University of Pennsylvania (Philadelphia, PA)
- …and translational research studies led by the Susztaklab, including multi-site investigator -initiated projects such as Trident, PGDD, and KRAD. The role involves ... and research related presentations. Works closely with the Principal Investigator , manager, and study team to identify problems and...and in alignment with salary ranges based on external market data for the job's level. Internal organization and… more
- University of Pennsylvania (Philadelphia, PA)
- …spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different interventions and varying complexities. Research coordinator ... and regulatory, and train them in these tasks. Attend Investigator Meetings and communicate meeting information to the study...and in alignment with salary ranges based on external market data for the job's level. Internal organization and… more
- University of Pennsylvania (Philadelphia, PA)
- …manuscripts, grant proposals, and presentations. Works closely with the Principal Investigator , manager, and study team to address study needs, implement approved ... changes, and monitor outcomes. Contributes to investigator -initiated, multi-center, and patient-oriented clinical and translational research studies. Job Description… more