Clinical Research Associate II

POSITION SUMMARY:

Responsible for ensuring participating Steward Hospital’s clinical research activities are conducted in compliance with Steward-wide and institutional SOPs, federal, state, and local rules and regulations, and ethical principles regarding the use of human subjects in research. Responsible for ensuring that research activities at the Steward Hospital involving human subjects are conducted in a manner that protects the safety, rights, and welfare of participants.

KEY RESPONSIBILITIES

• Performs a detailed analysis of all submissions (IRB and HIPAA related) for completeness, accuracy, ethical and regulatory compliance
• Provides instruction and advice to faculty and research staff on the regulations and on preparation of IRB applications
• Develops and implements IRB/HIPAA forms
• Identifies and resolves potential problems with all submissions ensuring that complete and accurate information is provided to the IRB
• Considers the nature of the proposed research and makes a determination regarding the necessary review process (expedited, exempt or full committee)
• Demonstrates sound judgment, as well as analytical, organizational and time management skills
• Provides technical support and guidance on regulatory matters at IRB meetings
• Documents the IRB’s determinations in the drafting of comprehensive meeting minutes and correspondence to investigators that effectively outline the concerns, rationale and technical questions of the IRB
• Conducts evaluations of the investigator’s response to IRB concerns and determines the adequacy and completeness of the investigator responses, requesting additional material or information in order to address the concerns and advises as to whether the requirements for IRB approval have been met
• Assists in the evaluation and acquisition of protocol tracking software. Interface with vendor on upgrades and modifications. Prime contact with vendor on all issues
• Documents the review process through complete and timely entries in the IRB online submission and protocol tracking system
• Participates in identifying needs and makes recommendations in the operations of the IRB and IRB office
• Works with Steward to develop and maintain research administrations websites.
• Provides back-up support to the IRB Manager
• Provides assistance and participates in facilitating a monthly clinical research coordinator meeting
• Provides assistance in organizing and participates in all relevant institutional research educational activities related to human subjects’ protections and IRB operations
• Assists in the identification and recruitment of new IRB committee members
• Acts as a resource to other Steward hospital IRBs

REQUIRED KNOWLEDGE & SKILLS:

Works closely with the Chair of the IRB

• Functions as a liaison within and between the IRB Committee, physicians, investigators, research staff, and research administrative staff at St. Elizabeth’s and other researchers at Steward Hospitals.
• Ability to effectively and pleasantly communicate with diverse populations within Steward Health Care.

EDUCATION/EXPERIENCE/LICENSURE/TECHNICAL/OTHER:

Minimum Education: Bachelor’s degree

Minimum Experience: 2-3 years in IRB office, IRB Administration, clinical research or other human subjects protection-related job

Minimum skills/abilities: Basic knowledge of clinical research and familiarity with medical terminology

Excellent time management skills with ability to independently prioritize, organize and efficiently deal with multiple ongoing activities

Excellent communications and interpersonal skills and ability to pay attention to detail

Certification/Licensure: Certified IRB Professional is preferred.

Training: A working knowledge of federal regulations pertaining to research, ICH GCP and HIPAA

Special Qualifications:

MS word and MS windows and experience with computerized databases

Have the ability to make accurate and appropriate independent judgments and know when to refer issues to supervisor

Exceptional analytical ability