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Clinical Research Regulatory Specialist

Medix The Bronx Full-Time
$27.00 - $28.00 / hour
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Overview

Coordinates and guides the review and approval process of all research activities associated with complicated clinical research studies involving human subjects ensuring the protection of their safety, rights, and welfare.Interprets and applies rules and regulations. This is a Direct Hire opportunity!
Responsibilities

  • Determines and interprets applicable rules and regulations associated with complex clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare. Collaborates with the Office of Research Integrity and Compliance and Corporate Compliance to ensure ongoing compliance.
  • Guides and coordinates all clinical trials-related submissions, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.) recommending alternatives to ensure compliance and approval. Submits such documents to the IRB and other internal/external regulatory and oversight groups. Works with these groups to address any questions or concerns.
  • Acts as a liaison between affiliate institutions, study sponsors, study coordinators, investigators and appropriate oversight/regulatory agencies when questions, issues, problems arise regarding study status and process. Serves as a resource to the clinical research office staff on regulatory concepts.
  • Researches new and updated rules and regulations associated with clinical research studies and trials involving human subjects. Provides guidance and training to research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects. Creates and ensures submission of appropriate documents associated with new projects, amendments, adverse events, informed consent, revisions etc. to the IRB and other appropriate internal/external oversight groups.
  • Determines compliance-required documentation and drafts necessary items such as protocols, informed consent, etc. Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers.
  • Provides guidance and training to research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects.
  • Alerts appropriate staff to changes and ensures appropriate interpretation and application to new and existing studies and trials.
  • Creates reports, summaries and analysis in regard to compliance requirements recommending changes in practice or procedure to increase effectiveness and efficiency of compliance.
  • Assists Division Administrator and/or Clinical Research Manager in maintaining department's research compliance program by ensuring adherence to all institutional policies and procedures, federal, state, and other funding agency rules and regulations. Provides guidance and training to investigators and research support staff on applicable rules and regulations. Compliance program components include, but are not limited to research safety, effort reporting, and conflict of interest reporting.
  • Other job functions as assigned.

Qualifications

  • Bachelor's degree or the equivalent and three years of work experience in a regulatory and/or research environment having developed a strong working knowledge of clinical research protocols required.
  • Detailed knowledge of federal, state, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research. Working knowledge of local and federal regulations for human subject research (ICH-GCP, OHRP, FDA regulations).
  • Excellent customer service, project management, and process improvement skills. Ability to take initiative, prioritize tasks to meet deadlines, produce results and cope with the inherent pressures.
  • Excellent organizational and analytical skills: ability to apply sound judgment and take initiative in collection of information from a wide variety of sources; ability to identify and resolve issues.
  • Excellent oral and written communication skills; effectively communicates with all levels of the organization; good presentation and training skills.
  • Ability to perform multiple tasks with a high level of accuracy and attention to detail.
  • Proficient computer skills (Excel, Word, Outlook, Access, PowerPoint; electronic medical record (EPIC).
  • Ability to identify, research, and solve problems.
Qualifications Bachelor's degree or the equivalent and three years of work experience in a regulatory and/or research environment having developed a strong working knowledge of clinical research protocols required. Detailed knowledge of federal, state, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research. Working knowledge of local and federal regulations for human subject research (ICH-GCP, OHRP, FDA regulations). Excellent customer service, project management, and process improvement skills. Ability to take initiative, prioritize tasks to meet deadlines, produce results and cope with the inherent pressures. Excellent organizational and analytical skills: ability to apply sound judgment and take initiative in collection of information from a wide variety of sources; ability to identify and resolve issues. Excellent oral and written communication skills; effectively communicates with all levels of the organization; good presentation and training skills. Ability to perform multiple tasks with a high level of accuracy and attention to detail. Proficient computer skills (Excel, Word, Outlook, Access, PowerPoint; electronic medical record (EPIC). Ability to identify, research, and solve problems.

Skills required

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$27
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Job ID: 84136

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