- Insmed Incorporated (San Diego, CA)
- …FDA and with other Health Authorities (such as EMA and PMDA)Support and monitor the development of new/revised regulatory requirements or procedures and ... day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've...therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …outstanding leadership skills based on a sound knowledge of clinical research standards and GCP.Develop operational strategies for ... working closely with our QA organization to implement ongoing learnings from regulatory inspections.Engage and motivate Clinical Operations employees to execute… more
- Merck & Co. (Rahway, NJ)
- …and key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability ... the protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development plans, clinical protocols, and in the submission of certain regulatory documents, as well as supporting commercial in developing a strategy including ... interact with key external experts, defining scientific questions to be answered. Monitor progress toward goals of external research programs.- Construct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(QQRs) and Quality Review Boards (QRBs).Collaborate with business process owners to monitor the effectiveness of clinical development processes through KQIs, ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Reporting… more
- Eisai, Inc (Nutley, NJ)
- …and an advocate for patient access to appropriate therapeutic alternatives. Monitor current methodological, clinical practice and professional guidelines, ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… more
- Insmed Incorporated (San Diego, CA)
- …closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs, and external partners.ResponsibilitiesEDC ... technical expertise and system documentationEnsure data integrity, system reliability, and regulatory compliance across all phases of clinical developmentTeam… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Manage… more
- Merck & Co. (Durham, NC)
- …providing end-to-end manufacturing science and technology support for LVV products. Monitor site-specific and cross-site issues, identify trends and participate in ... strong and trusting relationships with site technical operations, quality, regulatory , stability, and other stakeholders to ensure effective communication of… more
- Formation Bio (New York, NY)
- …pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Eisai, Inc (Pittsburgh, PA)
- …customer business, disease state, product prescribing information, approved promotional clinical trials, patient access to medication, and regulatory /compliance ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… more
- Edwards Lifesciences (Austin, TX)
- …Join us and be part of our inspiring journey. We are searching for a **Senior Clinical Research Monitor ** to join Edwards Aortic Field Monitoring team. As a ... Senior Clinical Research Monitor , you ensure... trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. + Develop… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …always rewarding. **It's Work That Matters.** **Overview** **Purpose Statement/Position Summary:** The Clinical Research Monitor Sr. serves as a senior-level ... continuous improvement in research quality. Additionally, the Clinical Research Monitor Sr. contributes...better serve our patients and create a strong community at CHLA. Clinical Research Regulatory … more
- Beth Israel Lahey Health (Boston, MA)
- …making a difference in people's lives.** The Sr. Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel Deaconess ... submit applications, including preparation of consent forms to the IRB on all clinical trials (industry, cooperative groups and PI initiated studies), and respond to… more
- University of Colorado (Aurora, CO)
- …year basis. **Preferred Qualifications:** + Experience in industry and/or PI initiated sponsored clinical research trials. + Regulatory experience + HIPAA ... etc. + Ensure adherence to local, federal, and institutional research regulatory standards and guidelines. + Manage...qualifications may be considered. + One (1) year of clinical research , grants management ( pre-or post-award)… more
- University of Pennsylvania (Philadelphia, PA)
- …binder for each study. Prepare and process all regulatory documentation with research sponsors and clinical research organizations (CROs). Obtain the ... of each subject. Resolve data queries with sponsors/CROs. + Monitor adherence to protocol throughout enrollment in study. Notify...Prepare and process all regulatory documentation with research sponsors and clinical research … more
- Mount Sinai Health System (New York, NY)
- …The **Project Manager II** will oversee the entire portfolio of Investigator-Initiated Clinical Trials (IICTs)/ Clinical Research Sponsor Collaboration (CRSC) ... implementing, and overseeing comprehensive training programs for new staff within the clinical research teams. This role ensures that new employees are… more
- Stanford University (Stanford, CA)
- …of patient and research data in appropriate files per institutional and regulatory requirements. + Participate in monitor visits and regulatory audits. ... Clinical Research Coordinator Associate **School of...management and implementation of an assigned set of multiple research protocols assuring efficiency and regulatory compliance.… more
- University of Utah (Salt Lake City, UT)
- …for two years of related work experience); and four years of clinical research experience that includes regulatory compliance monitoring/auditing, ... or religious beliefs that object to vaccinations. Preferences include credentialing as a Certified Clinical Research Associate ( CCRA ), Certified Clinical … more
- University of Miami (Miami, FL)
- …The University of Miami/UHealth Department OBGYN has an exciting opportunity for a full-time Clinical Research Coordinator 3 to work in Miami, FL. The ... Clinical Research Coordinator 3 (A) serves as... Coordinators. The incumbent monitors and maximizes adherence to research standards and regulatory guidelines and approved… more
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