- IQVIA (Durham, NC)
- …Instructions (WIs), quality of designated deliverables and project timelines. * Perform start up and site activation activities according to applicable ... sites and internal project team members. * Prepare site regulatory documents, reviewing for completeness and accuracy. * Ensure...documents for individual sites. * Review, track and follow up the progress, the approval and execution of documents,… more
- University of Pennsylvania (Philadelphia, PA)
- …of the initiation of Phase I-V clinical trials with a focus on required regulatory start - up approvals and associated site initiation documentation. Reporting ... The CRU OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs Start - Up Specialist-CC to facilitate, with minimal supervision, the … more
- University of Miami (Miami, FL)
- …state, and federal regulations (FDA, NIH, ICH-GCP) and institutional policies. + Oversee regulatory start - up activities for new clinical trials, including ... Pulmonary Medicine, has an exciting opportunity for a full-time Regulatory Specialist to work on the UHealth campus. The... Specialist to work on the UHealth campus. The Regulatory Specialist assists with the preparation and maintenance of… more
- Houston Methodist (Houston, TX)
- …Harmonization (ICH). This position will work closely with the study teams for study start - up regulatory paperwork, maintain regulatory documents such as ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating...position is responsible for coordinating and performing study specific regulatory processes such as local IRB and external IRB… more
- University of Miami (Miami, FL)
- … Analyst II reviews, prepares, and provides oversight for initial and subsequent regulatory submissions from study start - up through study closure as ... well as the maintenance of regulatory documents to ensure compliance with applicable requirements and...the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for… more
- Johns Hopkins University (Baltimore, MD)
- …**_Clinical Research Regulatory Specialist_** who will be responsible for managing regulatory start - up of clinical trials, assisting development of ... and continuing education trainings for the specific Urology Clinical Research Program. Regulatory start - up activities include site evaluation visits,… more
- Kelly Services (Riverside, CA)
- …+ Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start - up activities. + Provide ... Study Start - Up Site Manager **Study Start...Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). +… more
- Mount Sinai Health System (New York, NY)
- …Staff regarding specific protocols. + Manage clinical trials portfolio and assure timely regulatory start - up of protocols. + Monitor accruals and identify ... study enrollment, establishing a database of patients, protocol treatment and follow- up care for patients participating in clinical trials. + Collaborates with… more
- University of Miami (Miami, FL)
- …and/or Director of Regulatory with the day-to-day operations related to study start - up activities and regulatory maintenance of study records. CORE JOB ... SCCC has an exciting opportunity for a Full Time Regulatory Analyst 3 to work at the UHealth Medical...federal regulations. This process will take place from study start - up throughout the completion of the study.… more
- Vitalief (New Brunswick, NJ)
- …(for Industry, NIH, Cooperative Group, NCI and Investigator Initiated sponsored trials); Regulatory work required for start - up documents; Processes related ... work for Industry, NIH, Cooperative Group, NCI and Investigator Initiated sponsored trials; Regulatory work for start - up document; Contract review and… more
- University of Pennsylvania (Philadelphia, PA)
- …platform. Responsibilities include preparing and processing regulatory documents to all regulatory committees from study start up to study completion. ... include preparing and processing regulatory documents to all regulatory committees from study start up to study completion. Interacting with study… more
- University of Pennsylvania (Philadelphia, PA)
- …A Job Responsibilities + Manage single and multi-site clinical trials (including study start up , regulatory submissions, daily operations, external site ... + Manage single and multi-site clinical trials (including study start up , regulatory submissions, daily operations, external site communications… more
- Colorado Springs Utilities (Colorado Springs, CO)
- ** Regulatory and Compliance Internship** Job Type: **Internship** Pay Range **$21.62 to $28.55** Location **Colorado Springs, CO** Date First Posted **1/30/25** ... after a minimum of 5 days of being posted._ ** Regulatory and Compliance Internship** Colorado Springs Utilities is seeking...employees accrue 13 days of paid time off to start , while our more tenured employees accrue 24 days… more
- J&J Family of Companies (Spring House, PA)
- …plans, protocols, case report forms, operational & analytic plans o Execution: regulatory / ethics committee applications, start - up , enrolment, medical ... biostatistics, data science, medical writing, clinical operations, medical safety, regulatory affairs, quality, medical affairs, commercial and market access. Beyond… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …portfolio. We believe the Director is tasked with the management and oversight of study start up activities for the portfolio of studies as well as oversight and ... at least 11 years of experience within the clinical trial management with a focus on Study Start Up . Does this sound like you? Apply now to take your first step… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …party auditors. + **Clinical Trial Management** + Track and manage assigned new protocol start - up packet; initiate, facilitate and monitor study start - up ... The Regulatory Coordinators (RC) works under the direction of...and collaborate with clinical trial key stakeholders through the start - up process, provide regular updates and ensure… more
- Teva Pharmaceuticals (West Chester, PA)
- Director, Clinical Start - Up Lead, West Chester, PA Date: Jan 9, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job ... and new people to make a difference with. **The opportunity** As the **Director, Clinical Start - Up Lead,** you will play a pivotal role within the Global Clinial… more
- University of Miami (Miami, FL)
- …sponsors. Provides regulatory support for multiple clinical trials from study start - up through study closure. Generates and updates essential regulatory ... has an exciting opportunity for a Full Time Remote Regulatory Analyst 1. CORE JOB SUMMARY: The SCCC department...submission to the Institutional Review Board (IRB) from study start - up to study closure, including communicating with… more
- 3M (Monroe, NC)
- …with regulatory authorities, notified bodies, or agencies with any post-market follow- up activities or issues. + Performing routine regulatory tasks for new ... Job Description: Job Title Certification and Conformance Regulatory Affairs Associate Collaborate with Innovative 3Mers Around...with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact… more
- Delek US Holdings (Dallas, TX)
- Manager, Regulatory Compliance - Plano, TX Location: Dallas, TX, US, 75024 Are you looking for a career in a dynamic and innovative company that values versatility, ... a year. **DELEK BENEFITS** We offer fantastic benefits that include up to a 10% match on 401K on your hire start , with a vesting timeline of only one year, along… more