- Alternate Solutions Health Network LLC (Columbus, OH)
- …methods to ensure patient and family understanding.Policies: Completes all clinical documentation following agency protocol and Medicare/Federal guidelines.Rules ... and Regulations: Understand and follow agency policies, procedures, rules, and regulations and communicate changes in schedule/availability to schedulers or supervisors.Operations: Attend in-service training and mandatory agency meetings.HARD & SOFT… more
- Eisai, Inc (NJ)
- …Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' ... obtain all applicable source materialCollaborate with cross functional teams like Clinical Research, Biostatistics, Statistical programming, Clin Ops. etc. to ensure… more
- Insmed Incorporated (Bridgewater, NJ)
- …the bioanalytical strategy specific to clinical development programs.Participate in clinical study design and documentation (lab manual, protocol, report, ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA ( Clinical Research Associate) and/or CRA Manager, acts as primary site contact and site manager-throughout all phases of a ... clinical research study, taking responsibility of allocated sites.Develops strong...in a timely manner.-Collects, reviews, and monitors required regulatory documentation for study start-up, study-maintenance and study close-out.Communicates with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …experience with Quality Assurance oversight and support for all phases of Clinical and Production documentation and processes Knowledge, Skills, and Abilities: ... is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …goal to ensure GCO/ clinical teams are prepared and trained and study documentation is quality controlled and available, and all can withstand the scrutiny and ... areas centered around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, in ... adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...as outlined in QOP. Additional responsibilities include review and documentation of CRO-generated reports such as trip reports, protocol… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, ... local Investigator Meetings if requested to.Interface with GCTO partners on clinical trial execution.Escalates site performance issues to CRM and Clinical… more
- Atrium Health (Charlotte, NC)
- …of clinical , regulatory, business, and other research- related activities and documentation for clinical trials conducted by the Levine Cancer Institute, ... including FDA/OHRP guidances, GCP and ICH. Essential Functions Assists with clinical , regulatory, business, and other documentation associated with oncology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for ... streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience ... to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good ... Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...to the CSOP and manage the overall implementation and documentation of the CSOP, including activities conducted by CROs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical ... and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct,...to the CSOP and manage the overall implementation and documentation of the CSOP including activities conducted by CROs… more
- Atrium Health (Charlotte, NC)
- …activation programs. This leaders will be a key subject matter expert for clinical documentation and risk adjustment coding within the enterprise. This position ... Enterprise Population Health within the Southeast region. The Manager of Clinical Documentation Integrity is responsible for the clinical and administrative… more
- UNC Health (Chapel Hill, NC)
- …for rendered services. This individual is highly developed in assessing clinical documentation for medical necessity, patient status determination, knowledge ... communities we serve.RN Utilization Manager position specifically for a Utilization Manager/ Clinical Appeals Nurse. This person is based at the Hedrick building… more
- Alternate Solutions Health Network LLC (Detroit, MI)
- …with the PTAs and nurse aides on supervisory visit resultsCompletes all clinical documentation in accordance with agency protocol and Medicare/Federal ... the safety of the patient. You are accountable for completing accurate documentation and remaining compliant with all legal rules and regulations.QUALIFICATIONS &… more
- Marion County (Salem, OR)
- …outside professionals, and the community. Documentation Maintain accurate and timely clinical documentation in accordance with Federal, State, County, and ... and their families, other agencies, and the public; prepare concise and complete clinical documentation related to individual treatment and progress in services… more
- Marion County (Salem, OR)
- …including crisis assessment and intervention. Documentation Maintain accurate and timely clinical documentation in accordance with federal, state, county, and ... and their families, other agencies, and the public; prepare concise and complete clinical documentation related to individual treatment and progress in services… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management, will be ... will also be responsible for the creation, management, and documentation of GCO's CRO SOP review and maintaining the...biotechnology experience in one or more key functions (eg clinical operations, clinical research, clinical … more
- Merck & Co. (Rahway, NJ)
- …Global Clinical Trial Operations) organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance ... in public disclosure of clinical trials and their results, document disclosure, and data...(Disclosure Medical Writer) will be primarily responsible for preparing clinical study registration and results disclosure postings in compliance… more
