- Merck & Co. (Durham, NC)
- …validation, and development processes as required.Identifies and addresses compliance , environmental, safety, and process deviations as appropriate and ... equipment used in vaccine manufacturing process.Schedules and performs environmental monitoring during processing and records results in the computerized database… more
- Merck & Co. (Durham, NC)
- …responsible for managing a team of individual contributors responsible for the environmental monitoring and routine release testing of BCG at the Teknika site in ... during audits and inspections (regulatory, internal, safety)Collaborate with site compliance team to ensure adherence to regulatory requirementsReview and approve… more
- Merck & Co. (Durham, NC)
- …and approve Performance Qualification documents pertaining to environmental monitoring and process qualification.Provides Quality input, direction, and approval ... attendance is required for, field-based positions; facility-based, manufacturing-based, or research -based positions where the work to be performed is located… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …+ Support compliance process development, documentation, and implementation + Support compliance monitoring and auditing program + Support AdHoc healthcare ... than 110 countries and regions. **_Position Overview:_** The Healthcare Compliance Specialist supports the North American Healthcare Compliance...a hyrbid role which requires 3 days at the Research Triangle Park office. Work is performed in an… more
- IQVIA (Durham, NC)
- … research infrastructure powered by technology and expertise around recruitment, operations, monitoring and compliance . The Global Head and VP, Clinical Site ... IQVIA, a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry, is looking for a Global… more
- Belcan (Durham, NC)
- Clinical Research Associate Job Number: 354420 Category: Research Scientist Description: Job Title: Clinical Research Associate Pay Rate: $24.6 /hr Location: ... program Job Description: Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP… more
- UNC Health Care (Chapel Hill, NC)
- …informatics, advanced epidemiologic and statistical methods, advanced microbiologic methods, and compliance monitoring and coaching. We believe success in our ... patients, staff, and visitors, and to contribute to infection prevention research to guide evidence-based practices. We approach all infection prevention activities… more
- Cambrex High Point (Durham, NC)
- …and methods. Trains and mentors other employees. Additionally, this role may research and implement new methods and technologies to enhance operations. Efficiently ... plans and conducts experiments with an increased degree of independence. Prepares research summaries and reports. Experienced with a wide variety of analyses and… more
- Cambrex High Point (Durham, NC)
- …and methods. Trains and mentors other employees. Additionally, this role may research and implement new methods and technologies to enhance operations. Efficiently ... plans and conducts experiments with an increased degree of independence. Prepares research summaries and reports. Experienced with a wide variety of analyses and… more
- CDM Smith (Durham, NC)
- …key technical specialists, project team members, and delivery managers * Preparing, monitoring , and managing project budgets and schedules while managing the firm's ... active in the industry organizations, keeping abreast of emerging research /best practices, and conference/committee participation in professional societies *… more
- IQVIA (Durham, NC)
- …Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of ... care or other scientific discipline required + Requires 5-7 years clinical research / monitoring experience or equivalent combination of education, training and… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …the IRB , contributing to development of CAPAs and root causes analyses for non- compliance events, and preparing for monitoring and audit visit and responding to ... the IRB , participating in interviews of Regulatory applicants, monitoring trends in actions items/findings from monitoring ...research and by addressing patient safety and regulatory compliance which impact on research quality and… more
- Lilly (Durham, NC)
- …The EM associate assists in the safe, compliant execution of the environmental monitoring (EM) program for the Research Triangle Park Facility for Lilly ... areas (a 24/7 operation). This role is responsible for process monitoring and improvement, issue resolution/investigation, EM data system steward, and acts… more
- North Carolina Central University (Durham, NC)
- …internal controls. + Identify problems and changing requirements. + May conduct research and recommend updates or changes to software applications to enhance ... disciplinary actions. + Ensure that operating decisions are in compliance with the various state and federal laws and...cultural challenges commonly faced by students at a major research university. + Mentor, coach, and develop the comprehensive… more
- United Therapeutics (Research Triangle Park, NC)
- …as follows:** **What We Do** We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, ... and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan… more
- IQVIA (Durham, NC)
- …in health care or other scientific discipline. + 5 years of clinical research / monitoring experience or an equivalent combination of education, training, and ... to discover a career with greater purpose, join us as we transform and accelerate research and development. As a Global Trial Manager, you will play a crucial role… more
- IQVIA (Durham, NC)
- …of each clinical trial. Assures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by ... document training requirements in LMS systems and assure project level compliance with study specific training requirements * Responsible for change management… more
- IQVIA (Durham, NC)
- …Overview** Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete ... and accurate Trial Master File delivery. **Essential Functions** * Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately… more
- Merck (Durham, NC)
- …validation, and development processes as required. + Identifies and addresses compliance , environmental, safety, and process deviations as appropriate and escalates ... used in vaccine manufacturing process. + Schedules and performs environmental monitoring during processing and records results in the computerized database system.… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …Position Summary/Description: This position is responsible for managing and monitoring financial activities in multiple Center's and Core Facilities that ... are part of the School of Medicine Finance and Research Service Center. Fund types managed include grants, contracts, trusts, trials, gifts, Medical Foundation,… more
