Clinical Research Regulatory Specialist I, Clinical Trials Unit

3 weeks ago


Chardon, United States University Hospitals Full time
Essential Functions
  • Comprehends knowledge of scientific concepts related to the design and analysis of clinical trials; how drugs, devices and biologicals are developed and regulated.
  • Ensures care of the participants, aspects of human subject protections and safety in the conduct of a clinical research study.
  • Encompasses study management and GCP compliance; safety management (adverse event reporting) and handling of investigational product.
  • Facilitates all elements of communication within the site and between the site and sponsor, CRO and regulators; understands teamwork skills critical to responsible conduct of clinical research.
  • Embraces the principles and practice of leadership and professionalism in clinical research.
Required For All Jobs
  • Performs other duties as assigned.
  • Complies with all policies and standards.
  • For specific duties and responsibilities, refer to documentation provided by the department during orientation.
  • Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.


Qualifications:
Qualifications Education
  • Bachelor's Degree and some related experience Required or
  • Associate's Degree with 4 years of clinical and/or research experience Required
Knowledge, Skills, & Abilities
  • Ability to prioritize the work of multiple projects. Required
  • Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. Required
  • Write and edit technical documents. Required
  • Ability to understand and communicate regulatory requirements to others. Required
  • Medical terminology. Required
  • Excellent verbal, written, interpersonal skills. Required
Physical Demands
  • Standing Occasionally
  • Walking Occasionally
  • Sitting Constantly
  • Lifting Rarely 20 lbs
  • Carrying Rarely 20 lbs
  • Pushing Rarely 20 lbs
  • Pulling Rarely 20 lbs
  • Climbing Rarely 20 lbs
  • Balancing Rarely
  • Stooping Rarely
  • Kneeling Rarely
  • Crouching Rarely
  • Crawling Rarely
  • Reaching Rarely
  • Handling Occasionally
  • Grasping Occasionally
  • Feeling Rarely
  • Talking Constantly
  • Hearing Constantly
  • Repetitive Motions Frequently
  • Eye/Hand/Foot Coordination Frequently

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