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IRB Specialist I, Center for Clinical Research

2 months ago

Chardon, United States University Hospitals Full time
A Brief Overview
The IRB Specialist serves at the crossroads of virtually all activity that occurs in the Clinical Research Center and is therefore a key position in this office. The major functions of the position include evaluating protocol submissions, advising investigators, supporting the IRBs and managing daily operations of the IRB Administration Office.
What You Will Do
  • Works to obtain and maintain a current understanding of Federal, State and local laws, regulations and guidelines governing human subject research (15%)
  • Reviews human research protocol submissions to ensure that the UHCMC clinical research activities are conducted in compliance with IRB policies, institutional SOPs and international, federal, state, and local rules, regulations and ethical principles regarding the use of human subjects in research. (30%)
  • Coordinates IRB meetings including preparation of the agenda and materials in addition to recording medical and ethical issues discussed to ensure accurate documentation of IRB determinations. (25%)
  • Functions as a liaison within and between the IRB committees, investigators and their designees, and Center for Clinical Research and Technology (CCRT) staff. (15%)
  • Participates in special projects. (15%)
Additional Responsibilities
  • 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:
Education
  • Bachelor's Degree in health sciences, bioethics or a related degree (Required)
Work Experience
  • 1+ years prior experience in research, research administration, regulatory affairs clinical and/or laboratory research. (Required) and
  • Preference given to those candidates possessing IRB experience. (Preferred)
Knowledge, Skills, & Abilities
  • Knowledge of medical concepts and terminology is helpful (Required proficiency)
  • Accurate typing skills. (Required proficiency)
  • Ability to articulate information in grammatically correct written form. (Required proficiency)
  • Must have excellent organization skills with attention to detail. (Required proficiency)
  • Works independently as well as in a team setting and meets deadlines. (Required proficiency)
  • Good attendance record. (Required proficiency)
  • Service-oriented, self-motivated, professional, discrete, and act with integrity. (Required proficiency)
  • Prefer knowledge of research regulations, both internal and external. (Preferred proficiency)
  • Understanding of current NIH, DHHS, OHRP, and FDA guidelines governing human subjects' research helpful. (Required proficiency)
  • Ability to perform multiple duties simultaneously and to manage occasional increased workload volumes. (Required proficiency)
  • Ability to prioritize and process IRB submissions in an expeditious and efficient manner. (Required proficiency)
  • Proficient in use of PC and all MS Office software (Required proficiency)
Licenses and Certifications
  • Certification in Human Subjects Protection (CITI) within 30 Days (Required)
  • Research certification. (Preferred)
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
Travel Requirements
  • 10%

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