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The Clinical Research Coordinator III works under limited supervision and runs portions of clinical trials, assists with orientation and training, obtains signature for informed consent, central lab management, data management, completes expectancy reports, monitors visit preparation, submits low institutional risk trials and tracks TJU IRB submission and approvals.
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The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the review and migration of Phase I-V clinical trial investigator site files to the Veeva SiteVault platform.
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Clinical Research Coordinator C (CRC-C): In addition to above, the CRC-C will have limited supervision from the project manager and will need to use more independent judgment when managing their assigned clinical trials.
$42,953 - $77,315 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Statistical Analyst A will use standard SAS and/or STATA programming skills to create analytical datasets from clinical trials, surveys and health care claims, to construct and standardize outcome measures and other analytical variables through data cleaning and data manipulation, to provide descriptive and analytical reports, and to perform specialized statistical analyses.
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Required: Must have experience as a Clinical Research Coordinator, -2 years+ of Chart review experience on EMR -2+ years of EDC data entry. Data entry, Chart Review, Clinical Research Coordinator.
$28 - $33 an hourRemoteExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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The Clinical Research Coordinator A will also be responsible for training new personnel who will be working on clinical trials within the division. The Clinical Research Coordinator A will recruit and screen patients as outlined in research protocols, will coordinate all research visit activities for assigned projects (including processing and shipping blood and urine samples), and will assist in the maintenance of research records in compliance with IRB and HIPAA regulations.
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Prior experience in providing MSL-level support to products or devices in endocrinology and/or rare disease, including KOL development, investigator-initiated clinical trials, publications and educational programs, highly preferred.
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Familiarity with gene therapy or rare disease therapeutics development process including patient selection for clinical trials. Demonstrated working knowledge of design controls, analytical, clinical, and manufacturing process validation requirements for IVDs, GCP, GLP, and GMP requirements; working knowledge of requirements for US and global regulatory submissions related to IVDs for use in clinical trials and for commercialization of companion diagnostics.
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PhD in Cell or Molecular Biology with over 10 years of biotech/pharma experience leading advancement of hit chemistry through DC selection, IND enabling studies and into clinical trials. Lead internal target selection, and validation (including assay development, compound screening, in vitro and in vivo pharmacology including in vivo PK/PD/efficacy models as well as additional studies (including toxicity) required to declare a compelling clinical candidate.
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Research, draft and review legislation and regulations pertinent to and/or affecting the DRPA, PATCO and/or subsidiaries, make analyses regarding their impact upon the DRPA, PATCO and/or subsidiaries; recommends guidelines, policies and procedures concerning compliance with applicable laws and regulations; coordinates legislative activity with the office of Government Relations.
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The Clinical Research Coordinator Sr. works under limited supervision to run portions of interventional clinical trials, which includes assisting with orientation and training, obtaining signature for informed consent, managing central labs, managing study data, preparing for monitor visits and audits, and submitting safety and compliance reports to the IRB.
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We are seeking a Veterinary Clinical Research Nurse to provide staff support for clinical trials including data entry, organizing, maintaining and assuring the accuracy of all study documentation under the direction of the supervisor.
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These responsibilities include, but are not limited to, all concurrent utilization review activities as it relates to telephonic review, all clinical pre-certification responsibilities, all retrospective review responsibilities and all insurance company and business office concurrent determination follow-up and communication.
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The Cell Therapy Specialist will also participate in processing cellular therapy products for investigational clinical trials including TCR Alpha Beta depletions, CD34 selections, and CAR-T and viral CTL manufacturing.
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SUMMARY JOB DESCRIPTIONThe Clinical Informatics Specialist’s primary roles are to provide project management, software support and training for the PHMC Health Network’s clinical systems, electronic medical record (EMR), and other applications.
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review clinical trials jobs Title: manager clinical Company: Cpc Clinical Research in Philadelphia, PA
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