- Sumitomo Pharma (Harrisburg, PA)
- …is responsible for the leadership, development, and management of clinical studies while building and maintaining relationships with investigators and key opinion ... and emerging issues. + Oversee project-related education of investigators, study site personnel, and study staff. + Responsible for leading clinical study … more
- University of Pennsylvania (Philadelphia, PA)
- …assigned. Job Description Job Responsibilities + Coordinate and manage patient-oriented studies in accordance with study protocols, ICH-GCP, federal regulations, ... participants, maintaining regulatory compliance, collecting and entering data, developing study materials, coordinating visits and meetings, assisting with staff… more
- Geisinger (Wilkes-Barre, PA)
- Job Summary Supports the conduct of research studies , research projects and related administrative tasks, under supervision. Job Duties + Assists in day-to-day ... project activities such as maintaining study documentation, attending and documenting study meetings, etc. + Conducts data entry and manages computer databases… more
- Sumitomo Pharma (Harrisburg, PA)
- …Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and ... and system work instructions. Provide support and guidance to study team members during the full lifecycle of the... team members during the full lifecycle of the study , including planning, set-up, maintenance, QC and closure of… more
- University of Pennsylvania (Philadelphia, PA)
- …with the development of investigator-initiated research protocols and development/maintenance of study specific case report forms and source document tools. They ... compliance, and ensure smooth transition of protocols from regulatory start up to study activation. They will assist the Director with facilitating and tracking the… more
- Parexel (Harrisburg, PA)
- …Partner is a crucial liaison for investigative sites throughout a study 's lifecycle, responsible for site start-up, activation, relationship management, recruitment, ... + Maintains a knowledge of assigned protocols + Conducts study start-up activities at the site level including but...relationships with Site Organizations and Strategic Partners + Provides study support on escalated site issues related to … more
- Parexel (Harrisburg, PA)
- …clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices ... Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the...of sites in a clinical trial. **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical trials… more
- University of Pennsylvania (Philadelphia, PA)
- …clinical trials and mentors Coordinators and Research Assistants. Participates in study team meetings, disease site group meetings, and ongoing protocol ... responsibilities: 1) Coordinate patient activities on DVT protocols: serve as primary study contact for providers, track patient referrals, screen patients for … more
- University of Pennsylvania (Philadelphia, PA)
- …Coordinate and complete visits for subjects in multiple trials. + Complete study assessments (vital signs), testing (EKG), phlebotomy, and lab processing and ... shipping per protocol. + Coordinate the administration of study medication, including monitoring subjects for post-administration adverse events or reactions. +… more
- University of Pennsylvania (Philadelphia, PA)
- …and requisite review committees. Regulatory applications may include new study submissions, pre-IND/Pre-IDE submissions, annual reports, amendments, adverse events, ... related to the conduct of the research by vendors. They will lead study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The… more
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