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Clinical Rheumatology Review Group Eligibility Liaison
4 months ago
Job Title: Rheumatology Review Group (RRG) Eligibility Liaison
Division: R&D / Global Drug Development
Functional Area Description: The RRG Eligibility Liaison (REL) employs scientific and technical expertise to track, coordinate and enforce the timely delivery of quality clinical/study data.
Position Summary /Objective:
• Responsible for ensuring site participants in screening are ready for
RRG review through site communication and clinical/study data coordination and
tracking.
• Manage communication of participant status with the RRG via email and REL progress
tracker.
Position Responsibilities • Completes training and remains current with RRG processes to respond to a site’s
questions related to Screening Eligibility
• Work closely with the sites to ensure completion of all activities within 15 days from
the screening visit and contact the country specific CTMs for support if required.
• Oversees and tracks site screening activities in the REL Progress tracker to ensure
completion of lab results, data entry and query resolutions within the 28-day
screening timeline.
• Reviews lab data to determine if lab retests may be required and/or any exclusionary
labs are present; contacts sites/CTM/lab/RRG as needed.
• Liaises with GTM and CTMs as needed to prompt site responsiveness.
• Determines when participants are ready for RRG eligibility review and notifies the
RRG.
• Works with sites and CTMs (when needed) to enable timely resolution of RRG queries.
• Tracks RRG Eligibility eCRF queries to resolution; issues re-queries as needed.
• Communicates with sites throughout the RRG eligibility review process to ensure
timely decisions can be made (including but not limited to communication regarding
status of lab results, RRG queries, disagreement with RRG decisions, etc.).
• Facilitates email communication between sites and the Lead RRG Coordinator and
RRG Lead Reviewer.
• Facilitates virtual meetings between sites and the RRG and/or Efficacy and Eligibility
Adjudication Committee when necessary.
Degree Requirements
• Bachelor’s degree preferred
Experience Requirements • 2 to 5 years of experience in clinical research or equivalent (industry, academic or
study site experience is acceptable)
• Proficient knowledge of GCP/ICH, drug development process and clinical trial
operations.
Key Competency and Requirements
• Extensive proficiency in Microsoft Office software and Electronic Data Capture (e.g.,
RAVE)
• Must have strong interpersonal skills, be a team player and be willing to work in an
environment where individual initiative and accountability to the team are required.
• Excellent verbal, written and communication skills.
• Detail-oriented with a commitment to quality.
• Proficient in medical terminology with the ability to assimilate technical information
quickly.
• Proficient knowledge of the disease area(s) is preferred
• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting
priorities as well as an ability to meet day-to-day challenges with confidence and
professionalism.
• Proficient planning/project management skills.
Travel Required No travel required.
