- BeOne Medicines (San Mateo, CA)
- …such as country heads + Monitors study activities in region to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations + ... regional study budgets + Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities +… more
- Merck (Albany, NY)
- …**_Compliance and Ethical Leadership_** + Models and enforces the highest standards of ethics and compliance ; ensure all team activities adhere to company ... guidance (including safe field practices such as driver safety). + Owns compliance readiness: continuously assess compliance risks, implement preventive measures… more
- Teleflex (Minneapolis, MN)
- …and remote monitoring visits as well as centralized monitoring in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, Teleflex ... accordance with Teleflex procedures and applicable regulations to evaluate protocol compliance , data accuracy, and subject safety by review of regulatory documents,… more
- Abbott (Pleasanton, CA)
- …recruitment and data collection performance (enrollment, discrepancy resolution, compliance , etc.). Proactively utilizes appropriate operational metrics to minimize ... screen failure, attrition rate, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive… more
- Abbott (Pleasanton, CA)
- …recruitment and data collection performance (enrollment, discrepancy resolution, compliance , etc.). Proactively utilizes appropriate operational metrics to minimize ... screen failure, attrition rate, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive… more
- Astellas Pharma (San Diego, CA)
- …Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the ... CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good… more
- AbbVie (Irvine, CA)
- …820, ISO 13485 and ISO 14971. AbbVie, Irvine internal requirements include compliance with ethics , environmental health and safety, financial, human resources, ... completing regulatory submission-related studies (ISO 10993), performing life cycle compliance -related activities, and developing scientific messaging for advertising/promotional support.… more
- Colorado State University (Fort Collins, CO)
- …Position Summary In addition to compliance with safety, operational, regulatory compliance , and ethics training and procedures associated with the NASEM , ... manuscripts to scholarly journals + Attend meetings with principal investigator , funding agencies, and regional/national conferences as appropriate Required Job… more
- Teleflex (Minneapolis, MN)
- …this position develops and assesses SOPs, assesses processes for efficiency and compliance . This position requires the ability to be detail-oriented, organized, and ... site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance , and enrollment. * Lead study meetings to ensure completion of established… more
- Mount Sinai Health System (New York, NY)
- …as part of a team. + Familiarity with IRB processes, research ethics , and HIPAA compliance (preferred). **Responsibilities** **Patient Recruitment & Enrollment** ... and recruit eligible patients into study protocols. + Obtain informed consent in compliance with institutional and federal guidelines. + Serve as a primary contact… more