- Parexel (Frankfort, KY)
- …Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the ... audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures...in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential… more
- Parexel (Frankfort, KY)
- The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials ... and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable… more
- Parexel (Frankfort, KY)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical ... and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for… more
- Parexel (Frankfort, KY)
- The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the ... audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures...in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential… more
- Parexel (Frankfort, KY)
- …ensure site readiness for First Subject First Visit (FSFV) + Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation ... ICH-GCPs, and other applicable requirements **Skills:** + Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements + Must… more
- Parexel (Frankfort, KY)
- …Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your ... Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group...for the more senior roles of Senior Project Leader, Associate Project Director, and Project Director. To excel in… more
- GRAIL (Frankfort, KY)
- …and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome ... + MS or PhD with 10+ years of experience in regulatory, development, clinical affairs, quality, or program management within the IVD, medical device, or… more
- Parexel (Frankfort, KY)
- …Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for ... and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to… more
- Olympus Corporation of the Americas (Louisville, KY)
- …and able to travel overnight by car or air. **Preferred:** + Associate degree and/or Surgical Technician certification/degree preferred, or enrolment in accredited ... program. + Minimum of 1-3 years' experience in a clinical setting in support of patient care and/or equipment support in endoscopy, hospital, OR ambulatory surgery… more
- Abbott (Louisville, KY)
- …planning, organizing and performing work; monitors performance and reports status to manager. As a Clinical Associate on the US Abbott EP team, you will provide ... clinical and technical support in a hospital setting, utilizing...lab and/or operating room setting. + Acting as a clinical interface between the medical community and the business.… more
- Fujifilm (Frankfort, KY)
- **Position Overview** The Associate Clinical Specialist independently provides customer support of Fujifilm's ES equipment in the Endoscopy department and/or ... catalog for assigned customers. It serves as the primary clinical resource for the Company and its sales team...and prevent future handling damages. + Serve as a clinical liaison by developing and delivering comprehensive weekly and… more
- Sumitomo Pharma (Frankfort, KY)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate ** **Medical Director, Clinical Development - Oncology** . The ... director is responsible for the leadership, development, and management of clinical studies while building and maintaining relationships with investigators and key… more
- ChenMed (Louisville, KY)
- …We're rapidly expanding and we need great people to join our team. The Clinical Director will directly supervise and train primary care providers (PCPs) in his/her ... accountable for maximizing overall core model execution, including improving clinical quality, efficiency, outcomes, and clinician/patient satisfaction. In addition… more
- Humana (Louisville, KY)
- …caring community and help us put health first** Position Summary: The Vice President & Associate General Counsel - Clinical Operations is a key member of the ... Washington, DC; Chicago, IL **Key Responsibilities:** + Lead the work of the Clinical Operations team in the Law Department (including lawyers, paralegals and other… more
- ChenMed (Louisville, KY)
- …internal or family medicine who plays a key role as part of the clinical operations team providing direct patient care and providing assessments primarily in the ... service, productivity and teamwork. It also includes the participation in clinical rounds and conferences plus in-depth documentation through written progress notes… more
- CenterWell (Frankfort, KY)
- …part of our caring community and help us put health first** The Associate Director, Product Management Conceives of, develops, delivers, and manages products for ... customer use. The Associate Director, Product Management requires a solid understanding of...dynamic team of product management professionals dedicated to advancing clinical operations and technology solutions. Drive the strategic roadmap… more
- Sumitomo Pharma (Frankfort, KY)
- …Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable ... to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements.… more
- Parexel (Frankfort, KY)
- …we are expanding our esteemed Medical Sciences Team and seeking an Associate /Medical Director to support the growth of our Global Immunology and Inflammation ... Therapeutic Franchise. As an Associate / Medical Director, you will work closely with...the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical… more
- Otsuka America Pharmaceutical Inc. (Frankfort, KY)
- …needs and nutraceutical products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and ... responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a… more
- Sumitomo Pharma (Frankfort, KY)
- …a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part ... with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical … more
