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Human Safety & Protection Specialist

Job Attributes

Job Id:

16765

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20815

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Clinical Solutions is seeking a Human Safety & Protection Specialist in the Bethesda, MD area to support a well-established research organization focused on providing biopharmaceutical development support, health information services, and health & environment assessments for commercial and government clients.  

 

Responsibilities for the Human Safety & Protection Specialist: 

  • Provide expertise on the implementation of relevant Human Subjects Protection (HPS) regulations in support of ongoing clinical research trials
  • Conduct bioethical reviews of clinical trial protocols, including informed consent documents, literature reviews of ethical codes, regulations, and other documents relevant to human subjects protection to ensure compliance with regulations
  • Training and supervising staff on initiation of regulations and developing, reviewing, and updating informed consent templates, SOPs and guidelines to promote high quality patient interactions

Requirements for the Human Safety & Protection Specialist: 

  • 1+ years of experience in bioethics or a clinical research environment
  • Knowledge of regulations/policies relevant to the protection of human subjects in clinical trials
  • Experience with medical writing and IRB/GCP regulations
  • Ph.D. or a Master’s Degree in Science related field

Compensation for the Human Safety & Protection Specialist: 

  • Salary Range: $65,000-$75,000 based on relevant experience
  • Full Benefits: Health, Vision & Dental Insurance, 401K

 

Keywords:

 

CRO, Clinical research organization, clinical trials, pharmaceutical, biotechnology, biotech, gcp, good clinical practices, qms, quality management system, quality management plans, cqms, sop, standard operating procedures, protocol, quality assurance, qa, capa, investigations, audit, certified quality assurance auditor, CQA, clinical information. CIS, Clinical information specialist, Clinical Research Ethicist, HPS, human protection, clinical trial safety, human subject protection, GCP, IRB, international review board, FDA, pharmacology, toxicology, biochemistry, infectious disease

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Job Id:

16765

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20815

Security Clearance:

No Clearance

Business Unit:

Piper Companies