Maryland Oncology

Remote Regulatory Affairs Coordinator II - All TxO Locations


PayCompetitive
LocationDallas/Texas
Employment typeFull-Time

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  • Job Description

      Req#: 32000
      Employer Industry: Oncology Healthcare

      Why consider this job opportunity:
      - Opportunity for career advancement and growth within the organization
      - Supportive and collaborative work environment
      - Chance to make a positive impact on cancer care and patient outcomes
      - Involvement in cutting-edge research and clinical trials
      - Work remotely, providing flexibility in your work-life balance

      What to Expect (Job Responsibilities):
      - Assist with critical document collection and maintenance to facilitate the timely opening of trials and ensure audit-readiness
      - Communicate and collaborate with central operations to identify and resolve regulatory issues
      - Maintain protocol regulatory documents in compliance with local standard operating procedures
      - Assist with the preparation of informed consent documents and regulatory packets for sponsor and IRB submissions
      - Monitor and report serious adverse events (SAEs) to sponsors and IRBs

      What is Required (Qualifications):
      - High School Diploma required
      - Minimum of three (3) years of experience in clinical research, regulatory affairs, and/or an oncology-related field required
      - Experience in Microsoft Office
      - Exceptional communication skills and strong ability to multi-task
      - Excellent time management skills

      How to Stand Out (Preferred Qualifications):
      - Associate's degree in a clinical or scientific-related discipline preferred
      - Experience working with Sponsor Monitor representatives preferred
      - Background in clinical research, regulatory affairs, and/or an oncology-related field is preferred

      #OncologyHealthcare #ClinicalResearch #RemoteWork #CareerGrowth #PatientCare

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      We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
  • About the company