- Insmed Incorporated (Bridgewater, NJ)
- …internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non- clinical safety, contract research organizations ... our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1… more
- Nesco Resource (West Jefferson, OH)
- …to wear appropriate respiratory protection. Must be willing to be immunized with FDA licensed vaccines and Investigational New Drugs ( IND ) recommended for ... JOB SUMMARY s Biomedical Research Center is currently seeking an In-Vitro Assay/Microbiology...from in vivo pathogenicity/efficacy/toxicity studies as well as human clinical samplesSome assays include: bacterial enumeration, viral assays, ELISA,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Records, Electronic Signatures o 21 CFR 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary...cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... understanding of statistical methodologies and their application in the context of non- clinical studies and related projects in AD and other therapeutic areas as… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …About the Role:Job SummaryResponsible for the coordinating, implementing, and evaluating of clinical research trials. This includes all phases of research ... credentials. Other: Preferred Job QualificationsPreferred Licensure or other certifications: Clinical Research Certification or scheduled exam date.Preferred… more
- University of Miami (Miami, FL)
- …Minimum two (2) years of relevant experience in fields such as compliance, research , and/or medical/ clinical . IND /IDE/ FDA experience preferred. ... Submits or assists in the submission of applications for institutional clinical trials. Sends decision correspondence to appropriate parties, requesting information.… more
- Guidehouse (Bethesda, MD)
- …Public Trust **What You Will Do** **:** We are currently searching for a Clinical Research Protocol Navigator. The primary role for this Protocol Navigator (PN) ... position is to provide clinical research regulatory...other administrative documentation. + Develop new and review completed IND and IDE safety, clinical study reports… more
- Cedars-Sinai (Los Angeles, CA)
- …or aggressive tumors requiring a comprehensive and multidisciplinary approach. The Clinical Research Coordinator II works independently providing study ... clinicaltrials.gov listing requirements, and results reporting. + Supervises and provides training to Clinical Research Associate I (CRA I). + Works with RN to… more
- University of Pennsylvania (Philadelphia, PA)
- …website (https://coronavirus.upenn.edu/) for the latest information. Posted Job Title Clinical Research Coordinator B/C (Hybrid Eligible)(Abramson Cancer Center) ... Job Profile Title Clinical Research Coordinator B Job Description Summary...and execute studies. Be responsible for writing investigator initiated IND /IDE clinical trials in collaboration with faculty… more
- University of Pennsylvania (Philadelphia, PA)
- …of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is an integral and essential member of the ... and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator B/C (Abramson Cancer Center)(Hybrid Eligible) Job Profile… more
- Rockefeller University (New York, NY)
- …four years of Clinical Research Coordinator experience, including research in investigator-initiated research and IND /IDE trials. Advanced leadership ... four years of Clinical Research Coordinator experience, including research in investigator-initiated research and IND /IDE trials. Advanced leadership… more
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator C (Department of Dermatology) Job Profile Title ... Clinical Research Coordinator C Job Description Summary...and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines. + Participate in the development/maintenance… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …JOB DESCRIPTION: + This is a central job, reporting to the Office for Clinical Research (OCR). Responsible for the Prospective Reimbursement Analysis (PRA) for ... IND status in the study protocol, eIRB, or FDA study documentation. + Evaluates Category A and Category...third party payers. + Customizes the PRA for pediatric clinical research studies, utilizing Medicaid, Georgia statutes,… more
- University of Miami (Miami, FL)
- …policies and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best Practices. + ... The Department of Pathology and Laboratory Medicine is currently seeking a full time Manager, Clinical Research to work in Miami, FL. The Manager, Clinical … more
- Johns Hopkins University (Baltimore, MD)
- …experience in clinical research and regulatory affairs including FDA regulated trials ( IND /IDE). + Additional education may substitute for experience ... Division of Gastroenterology and Hepatology is seeking a **_Sr. Clinical Research Program Manager_** for the GI...Supervise and assist staff as needed on IRB and FDA submissions to ensure compliance. + Assist JHU faculty… more
- Northwell Health (Glen Oaks, NY)
- …site initiations and trainings. Job Responsibility 1.Trains, coaches, supports and mentors Site Clinical Research Managers and other team members. 2.Manages the ... clinical research sites including, but not limited to acting as...FDA which may include an Investigational New Drug ( IND ), Investigational Device Exemption (IDE), New Drug Application (NDA)… more
- Georgetown Univerisity (Washington, DC)
- …science related field + 3 to 5 years of regulatory affairs or clinical research experience + Strong working knowledge of FDA , NCI, OHRP, and Good Clinical ... making a difference in the world. Requirements Regulatory Associate, Clinical Research Management Office - Lombardi Comprehensive...Drug ( IND ) applications as required. + Maintain research practices using Good Clinical Practice (GCP)… more
- University of Pennsylvania (Philadelphia, PA)
- …programs and resources, and much more. Posted Job Title Developmental Therapeutics Clinical Research Nurse C/D (Hybrid Eligible)(Abramson Cancer Center) Job ... Profile Title Clinical Research Nurse C Job Description Summary...and execute studies. Be responsible for writing investigator initiated IND /IDE clinical trials in collaboration with faculty… more
- Boston University (Boston, MA)
- The Clinical Research Resources Office (CRRO ) is an office under the Human Research Protection Program (HRPP), which is a shared program of Boston Medical ... exceeds ethical and regulatory standards and adheres to best practices. The Clinical Research Resources Office (CRRO) Regulatory Education Manager will manage… more
- University of Pennsylvania (Philadelphia, PA)
- …wealth of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator C Job Profile Title Clinical Research ... ("Program") of the University of Pennsylvania seeks a full-time Clinical Research Coordinator C. This position will...and data quality; adhere to all University of Pennsylvania, FDA and GCP guidelines. + Collect, prepare, ship and/or… more
