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Athens, United States Maxis Clinical Sciences Full time $36 - $37Job DescriptionJob DescriptionJob Title: Senior Specialist, US Regulatory Affairs OperationsLocation: St. Joseph, MO or Athens, GA*Note requirement to be in the office 2-3 days a week.Independently support data maintenance and archival and retrieval of regulatory documentation in computerized systems.Assist with preparing high quality US regulatory...
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Facilities Operations Senior Manager
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Athens, Ohio, United States Ortho Clinical Diagnostics Full timeOpportunity Overview Ortho Clinical Diagnostics is a premier in vitro diagnostics organization that integrates the strengths of Quidel Corporation and Ortho Clinical Diagnostics. We are dedicated to delivering rapid, precise, and consistent testing solutions across a wide range of environments, from home to hospital and laboratory to clinic. Our workforce of...
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Athens, United States NewAge Clinical Full time $35 - $38Job DescriptionJob DescriptionReq Number: 33705637 Req Title: Senior Specialist, US Regulatory Affairs Operations Client: A major pharma company Work Address: 1730 Olympic Dr, 30601, Athens, GA Duration: 18 Months with possible extensionHours per Week: 40.0 (Location: St. Joseph, MO or Athens, GA (Note requirement to be in the office 2-3 days a...
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Pharmaceutical Research Associate
4 days ago
Athens, Georgia, United States University of Georgia Full timePosition OverviewRole SummaryThis position is for a Postdoctoral Research Associate within the College of Pharmacy at the University of Georgia. The successful candidate will engage in innovative research within the field of pharmaceutical sciences, contributing to both experimental design and execution.Institutional BackgroundThe University of Georgia,...
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Research Associate
4 days ago
Athens, Georgia, United States University of Georgia Full timePosition OverviewPosition Title: Postdoctoral Associate - JoynerDepartment: VetMed-Vaccines & Immun CtrAbout the University of GeorgiaEstablished in 1785, the University of Georgia stands as the oldest and most comprehensive institution of higher education in Georgia. With a commitment to academic excellence, UGA is consistently ranked among the top public...
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Lead Research Specialist
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Athens, Georgia, United States InsideHigherEd Full timePosition Overview:The role of the Senior Research Associate focuses on the intricate dynamics between human populations and wildlife in urban settings. This position is pivotal in addressing the growing concerns of human-wildlife interactions, particularly in metropolitan areas.Institutional Background:The University of Georgia, a distinguished institution...
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Research Associate in Aquatic Systems
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Athens, Georgia, United States University of Georgia Full timePosition OverviewPosition Title: Research Associate in Aquatic SystemsDepartment: Warnell School of Forestry and Natural ResourcesAbout the University of Georgia:The University of Georgia, established in 1785, stands as Georgia's oldest and most comprehensive institution of higher education. With a rich history of over 235 years, UGA is committed to academic...
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Lead Research Specialist
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Athens, Georgia, United States InsideHigherEd Full timePosition Overview:The role of Senior Research Associate focuses on the pressing issue of human-wildlife interactions in urban settings. As urban areas expand, the likelihood of negative encounters between humans and wildlife increases, necessitating informed management strategies.Institution Background:The University of Georgia, a prestigious institution...
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Lead Research Specialist
3 days ago
Athens, Georgia, United States InsideHigherEd Full timePosition Overview:The role of the Senior Research Associate focuses on addressing the complexities of human-wildlife interactions in urban settings. This position is critical as urbanized areas increasingly become habitats for wildlife, leading to potential conflicts with residents.Institution Background:The University of Georgia, established in 1785, stands...
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KPI Microbiome Research Associate
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Athens, United States Kelly Products, Inc. Full timeKelly Products Inc (KPI) is a medium business in Covington, GA. KPI is a multicompany organization including lifestyle brands such as Flavor and Fettle () and Farmview Market (). KPI has an expanding health focused group that is interested in developing new and innovative products focused on the microbiome from prebiotics and probiotics to naturally produced...
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Marine Microbiology Research Scientist
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Athens, Georgia, United States University of Georgia Full timePosition OverviewThe University of Georgia is seeking a dedicated Postdoctoral Research Associate to join our team within the Franklin School of Marine Programs. This role is integral to advancing our understanding of marine ecosystems through innovative research.About the RoleThe selected candidate will engage in a variety of research activities focused on...
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EHS Senior Associate
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Athens, United States Caterpillar Full timeCareer Area: Environmental Health and Safety Job Description: Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you're joining a global team who cares not just about the work we do - but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable...
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Genetics Research Associate
4 days ago
Athens, Georgia, United States University of Georgia Full timePosition OverviewRole: Postdoctoral ResearcherDepartment: Franklin-GeneticsAbout the Institution:The University of Georgia, established in 1785, stands as the oldest and most comprehensive institution of higher education in Georgia. With a rich history of over 235 years, UGA is consistently ranked among the top public universities in the nation. The main...
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Athens, Georgia, United States University of Georgia Full timePosition OverviewThe University of Georgia is seeking a dedicated Postdoctoral Research Associate to join our team in the Franklin School of Marine Programs. This role is essential for advancing our understanding of marine ecosystems through innovative research funded by the GoMRI ECOGIG Grant.Key ResponsibilitiesSample Preparation and Laboratory Work: The...
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Lead Research Specialist
2 days ago
Athens, Georgia, United States InsideHigherEd Full timePosition Overview:The role of the Senior Research Associate focuses on the critical examination of human-wildlife interactions within urban settings. This position is vital for understanding the complexities of wildlife management in densely populated areas.Institution Background:The University of Georgia, a prestigious institution founded in 1785, is...
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Senior Continuous Improvement Specialist
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Athens, United States Ortho Clinical Diagnostics Full timeThe Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with...
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Research Associate in Viral Pathogenesis
3 days ago
Athens, Georgia, United States University of Georgia Full timeDepartment OverviewDepartment of Infectious Diseases, College of Veterinary Medicine, University of Georgia.The selected candidate will collaborate closely with Prof. Biao He (Principal Investigator) on research initiatives aimed at elucidating viral pathogenesis and advancing vaccine development. Responsibilities include:Designing experiments and conducting...
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Senior Retail Sales Associate
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Athens, United States Harbor Freight Tools Full timeHarbor Freight Tools Senior Retail Sales Associate Athens , Alabama Apply Now 151480BRPosting Title:Senior Retail Sales AssociateJob Description: A Senior Retail Sales Associate (full-time) is a valued member of a high performing team who is empowered & equipped to do their job You will know why your work matters and be able to take pride in what you do!...
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Senior Research Scientist
5 days ago
Athens, GA, United States The University of Georgia Full timePosting Number:F1892PWorking Title:Senior Research ScientistDepartment:VetMed-Infectious DiseasesAbout the University of Georgia:Since our founding in 1785, the University of Georgia has operated as Georgia's oldest, most comprehensive, and most diversified institution of higher education ( ). The proof is in our more than 235 years of academic and...
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Senior Research Associate
5 days ago
Athens, GA, United States The University of Georgia Full timePosting Number: S06812PWorking Title: Senior Research Associate - Metropolitan Human-Wildlife ConflictsDepartment: Warnell-ResearchAbout the University of Georgia: Since our founding in 1785, the University of Georgia has operated as Georgia's oldest, most comprehensive, and most diversified institution of higher education ( ). The proof is in our more than...
Senior Clinical Research Associate
2 months ago
**Description****This is a hybrid position that requires onsite work 2-3 days a week, based on the team requirements. Remote work/high travel to the site is not an option. Employees must be within a commutable distance of the job location. Relocation packages are available to qualified hires.**As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.The Senior Clinical Research Associate (SCRA) supporting Environmental Fate and Exposure conducts in-house and external monitoring to verify that reported data collected in environment fate and exposure studies are accurate, complete, and verifiable from source documents and to ensure that the studies are conducted in compliance with the current approved protocol, GCP/OECD requirements, FDA/CVM Regulations, and BI SOPs. The SCRA is responsible for ensuring quality of study protocols, raw data, and reports to support registrations and other claims related to veterinary products and integrating this data into environmental assessments for predominantly off-site (national and global) environmental fate and exposure studies however the role may also support trials for all animal species and across all product modalities.The SCRA performs these duties for on-site and off-site (national and global) clinical studies and trials for all animal species and across all product modalities. Duties include interaction with CROs/Investigators, monitoring of study status, quality control and integrity of data, management of study data and procedures in compliance to GxP and relevant regulatory guidelines. The SCRA drafts protocols and reports and can act as a Study Leader for studies. The SCRA is responsible for tracking timelines and deliverables and interfacing with internal collaborators (e.g., clinical trial supply, data management, regulatory affairs, PV). The SCRA acts as a trainer, mentor, and resource to CRAs and Study Coordinators and acts as an expert in data and documentation quality.**Duties & Responsibilities**+ Responsible for appropriate quality of study protocols, raw data, and reports.+ Ensures all study/trial data are accurate, complete and verifiable from source documents (e.g., as subject research records, medical charts etc.) and regulatory documents.+ Responsible for protocol adherence and ensuring study documentation is completely and properly maintained in accordance with Sponsor protocol, BIVI SOPs, GCP/GLP/ VICH requirements and FDA regulations.+ Ensures deviations are identified and reported to the appropriate Study personnel.+ Responsible for quality control audits of data entry and statistical reports.+ Makes certain that all documents related to in-house, CRO, and field studies are accurate as to drug dosages, drug accountability, numerical calculations, concurrent medications, clinical signs when compared to clinic records, adverse events, clinical observations, and analytical results.+ Documents to be audited include, but are not limited to, study notebooks, study reports, protocols, study checklists, and analytical data.+ Responsible for identifying qualified CROs/FT Investigators.+ Conducts Investigation Site Visits to evaluate qualifications of the site, Investigator, and research staff.+ Conducts pre-study, ongoing, and study close-out monitoring visits complying with Guidelines for all study/trial sites.+ Verifies both individual subject and overall drug accountability.+ Monitors the progress of in-house studies, field studies, and contract laboratory clinical studies, and provides status reports on progression and quality of the animal or report writing phases of the study.+ Identifies problems with enrollment and mitigations to resolve the issues.+ Drafts protocols, amendments, deviations, and reports and can act as Investigator for in-house or outsourced studies.+ Monitors Adverse Event (AE) reporting and request primary and follow-up information.+ Provides information to pharmacovigilance and RA according to the study protocol and SOPs.+ Ensures availability of all final study documentation for audits/inspections (internal compliance or CVM).+ Prepares protocols, data, reports, and other documents for submission to regulatory agencies.+ Collaborates closely with Regulatory Affairs to align on document organization.+ Collaborates with the Scientist and study team in protocol development, CRF design, writing amendments, creating site-training materials, final study report, training materials, etc.+ Assists Scientist in planning and implementation of investigator meetings and/or webinars.+ Responsible for the creation and implementation of the study project plan including creating and monitoring timelines for deliverables under the oversight of the Clinical Scientist.+ Assists Scientist with budget development, budget management, and Investigator contract management.+ Assists Scientist in monitoring study trends (e.g., AE trends) and enrollment timelines to meet or exceed project team timelines and goals in line with the TPP.+ Develops and implements improvements for data collection and data processing.+ Recommends revisions to improve effectiveness of monitoring tools, study documents and study processes.**Requirements**+ Bachelor’s degree (prefer relevant disciplines such as biology, animal science, nutrition, etc.); MS preferred.+ Minimum of three to five (3-5) years’ experience as a CRA/Monitor or similar role.+ Good verbal and written communication skills (correspondence, protocols, reports, etc.)+ Good interpersonal skills. A collaborative team player.+ Possesses a customer service orientation, delivering results and executing in a fast and focused manner.+ Solid organizational skills with a quality orientation.+ Strives for business process excellence.+ Effective time management.+ Ability to work independently.+ High degree of attention to detail.+ Ability to find errors or inconsistencies others may miss.+ Accepts accountability and ownership.+ Exhibits integrity and trust.+ Willingness to travel up to 60% of time.+ English: Fluent (read, write and speak).+ Ability to communicate effectively both orally and in writing in an inter-disciplinary.+ Must have basic knowledge and experience in clinical medicine with an ability to evaluate data and scientific literature.+ Must understand and implement VICH GCP regulations; GLP is a plus.+ Certification from a recognized clinical research organization (e.g., ACRP or DIA) is preferred.**Eligibility Requirements** :+ Must be legally authorized to work in the United States without restriction.+ Must be willing to take a drug test and post-offer physical (if required).+ Must be 18 years of age or older.All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
