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Clinic Research Coordinator II The Clinical Research Coordinator II , will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor.
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Proficiency in electronic data capture (EDC) systems and clinical data management software. years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry.
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Experience with various clinical trial systems (EDC, CTMS, TMFs) trial master file organization, regulatory documents required. · Contribute to the development, review and approval of study documents including but not limited to protocol, ICF, multiple clinical trial plans, EDC/CRFs, pharmacy manual, oversight manuals, clinical study reports, patient narratives, and Clinical Trial Agreements.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures. the Sr. Clinical Trial Associate (CTA) position will assist with daily clinical trial execution activities including enrollment management, vendor oversight, and the coordination of documents associated with the conduct of investigational clinical studies in accordance with applicable regulations, Good Clinical Practice (GCP), and CRISPR Therapeutics standard operating procedures (SOPs.
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The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is a multidisciplinary, membership-based scientific organization that designs and conducts biomarker-driven cancer research clinical trials involving adults who have or are at risk of developing cancer.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Experience (6+ years) working in relevant clinical research, preferably in clinical operations within a pharmaceutical company or CRO or similar organization. Knowledge of regulatory requirements and guidelines governing clinical research.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Highly competent in clinical data management, various EDC systems, CDASH/CDISC standards and medical coding dictionaries. A minimum of 12-15 years of experience in a pharmaceutical industry or other clinical research setting with clinical trials; at least 10 years working with clinical data and clinical development processes.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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BA/BS degree preferred or associate degree and 3 years of professional experience working in a clinical research environment (clinical site, CRO or biotech/pharma company) or demonstration of equivalent capability in a Clinical Operations role.
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Exp./Familiar with EDC, Medidata, RedCap or Inform is a plus but not required. of industry clinical trial experience from CRO, Pharma, Biotech or Healthcare setting is required. Advise research sites on protocol conduct, interpretation of protocol, and ensure resolution of issues.
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Monitor clinical trial progress, in conjunction with the AFT In-House Clinical Research Associate (IHCRA), through a combination of remote data review and remote/on-site monitoring visits.
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PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance.
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Ensure proper completion of UAT of EDC system and modules. Review/prepare training materials and user guides for EDC data collection tools, deliver user training. Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system.
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Experience in the pharmaceutical or medical device industry as a clinical research professional, including successful clinical trial management role and hands-on managerial experience executing high quality clinical trials from inception to completion.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes. 5+ years relevant clinical research experience in the pharmaceutical industry, or a similar organization (e.g. CRO), including clinical trial leadership experience, Ph3 and global experience strongly preferred.
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