- Bausch + Lomb (Juneau, AK)
- …optimizing business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical , ... + Ensure operational excellence, compliance, and timely execution of deliverables. + Drive regulatory strategies for clinical , non- clinical , CMC and labeling… more
- Johns Hopkins University (Baltimore, MD)
- …Generate monthly enrollment and screening reports and submit to NIH via CROMS. + Monitor , document, and report adverse events to regulatory agencies. + Report ... **Specific Duties & Responsibilities** _Database Management_ + Maintain and update research databases, ensuring compliance with regulations and entry. + Develop data… more
- Abbott (Santa Clara, CA)
- …regulatory review. + Monitor and submit applicable reports to regulatory authorities. + Evaluate proposed preclinical, clinical and manufacturing changes ... for submission filing. + Compile, prepare, review and submit regulatory submissions to authorities. + Monitor impact...years of experience. + 2-3 years of experience in regulatory preferred but may consider quality assurance, research… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …program across the Institute. This role ensures that all operations, including clinical , research , and administrative functions, adhere to federal, state, and ... compensation). Provide expert compliance guidance to leadership, staff, and stakeholders. + Monitor changes in regulatory requirements, assess their impact on… more
- MD Anderson Cancer Center (Houston, TX)
- …and regulatory standards for proposals and activities. Partner with research administration, research finance and facilities teams to recommend and ... in directing, coordinating, and evaluating complex administrative operations across research , clinical , educational, and outreach activities, particularly within… more
- IQVIA (Durham, NC)
- …**\#LI-Remote** **\#LI-NITINMAHAJAN** IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence ... Clinical Operations with statistical expertise. + Contribute to clinical study reports and other regulatory documents...other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare… more
- Cleveland Clinic (Weston, FL)
- …risk assessment process and compliance committee activities in partnership with Institute clinical research leaders. Minimum qualifications for the ideal future ... degree in healthcare or science-related field and three years of required experience + Clinical Research certification from the Society of Clinical … more
- Johns Hopkins University (Baltimore, MD)
- …Program Coordinator_** who will coordinate multi- and single-center, federally- and industry-funded clinical research studies conducted in the ICU and post-ICU ... will perform, train and/or supervise duties, including consenting, collecting and entering clinical data, and carrying out related research duties for new… more
- Lilly (Indianapolis, IN)
- …byleveragingteam expertise, as well as scientific, drug/device clinical development and knowledgefromhealth authorities such as ... with Global Regulatory Team. + Continually expand therapeutic area knowledge. Monitor and assess impact of relevant global regulations, guidance, and current … more
- University of Washington (Seattle, WA)
- …research processes including study recruitment, enrollment, randomization, oversight of research regulatory requirements, data management and preliminary data ... results. **Position Complexities:** The position requires knowledge of clinical intervention research and randomized trials, experience...+ Assist in the development of study tools and research protocols + Complete and monitor human… more