- University of Michigan (Ann Arbor, MI)
- …CRO, and sponsors,Oversee EDC management, coordinating visits, PI and co- investigator communication. Develop new processes, implement novel gene correction, gene ... to prepare for regulatory audits and coordinate conduction with sponsors, principal investigator and regulators.Perform quality checks on work of others at this and… more
- Merck (Annapolis, MD)
- …line to ensure appropriate quality oversight of assigned studies. + Assesses compliance of clinical investigator sites, vendors, study activities, clinical study ... and perform risked-based audits + Activities may include GCP audits of investigator sites, suppliers, third party collaborations and due diligence activities. + In… more
- J&J Family of Companies (Horsham, PA)
- …development, regulatory communications, academic and community-based IBD HCP and investigator interactions, support of execution, and supervision of clinical studies ... all types, including: Phase IIIb/IV, registries, real world evidence, and investigator -initiated studies and collaborations supported by US Medical Affairs within… more
- University of Colorado (Aurora, CO)
- …+ Serve as the primary clinical research coordinator for investigator -initiated and clinical research protocols. + Collaborates with investigators, clinical ... procedures are performed per protocol and properly documented. + Ensure protocol specific compliance and compliance with FDA, OHRP, GCP, IRB, HIPAA, UCD, and… more
- Cedars-Sinai (Los Angeles, CA)
- …such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug ... timely manner. Projects may include but are not limited to investigator -initiated protocol development including protocol writing, case report form development,… more
- ConvaTec (Lexington, MA)
- …clinical trials, ensuring they are conducted efficiently, effectively, and in compliance with all relevant regulations including ICH GCP guidelines, local regulatory ... studies to assure adherence to timelines, budget and milestones while ensuring compliance with applicable SOPs, guidelines, and regulations. + Working closely with… more
- AECOM (Harrisburg, PA)
- …and data recovery efforts, analyze prehistoric and historic artifacts, and prepare compliance reports. Responsibilities include, but are not limited to: + Serves as ... experience in directing field crews under the guidance of the Principal Investigator or Project Manager including scheduling work and making individual or team… more
- Stanford University (Stanford, CA)
- … compliance . Regularly inspect study document to ensure ongoing regulatory compliance . + Work with principal investigator to ensure Investigational New ... Research Coordinator 2 - Blood and Marrow Transplantation and Cell Therapy (BMT-CT) ( Hybrid )** The Stanford Cancer Institute (SCI) is one of an elite number of… more
- University of Pennsylvania (Philadelphia, PA)
- …tracking deadlines to ensure timely and appropriate regulatory reporting and compliance for any/all clinical research conducted within the department/division. The ... of training programs for investigators to enhance understand of and compliance with applicable regulations. + The Associate Director for Regulatory Affairs… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …specified field while receiving advanced training from a designated Principal Investigator to enhance professional skills and research independence needed for ... + Prepares and publishes scientific manuscripts under the direction of the Principal Investigator . + May be responsible for operation of specific equipment. + May… more