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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory compliance and Institutional Review Board (IRB) processes, with a strong understanding of research regulations and guidance. Capable of effective communication and collaboration with diverse stakeholders in clinical research settings.
Highest-signal resume keywords
Regulatory ComplianceInstitutional Review Board (IRB) ExperienceCertified IRB Professional (CIP)Clinical Research KnowledgeVerbal Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Requirements KnowledgeResearch Regulations UnderstandingSubmission ReviewProtocol PresentationClinical Affairs Consultation
Soft Skills
Problem SolvingTeam BuildingMotivationMentoringCollaboration
Certifications & Qualifications
Certified IRB Professional (CIP)
Industry Keywords
Clinical ResearchHealthcareBoard Standard Operating ProceduresOrganizational PoliciesInstitutional Review Board
About the role
Key responsibilities & impact- Maintain superior knowledge of regulatory requirements, Advarra’s Board Standard Operating Procedures, and Organizational Policies and Procedures
- Ensure Review Board compliance with regulatory requirements and organizational procedures
- Help ensure timely execution of Institutional Review Board core review activities while maintaining professionalism and regulatory compliance
- Answer questions and solve day-to-day challenges with Advarra staff and other board members
- Assist with triaging and reviewing submissions for expedited or full board review
- Attend full board meetings and present protocol-related issues as needed
- Identify areas requiring guidance, inconsistencies in Board reviews, and similar issues to senior regulatory staff
- Consult with sponsors, investigators, and CROs on clinical and regulatory affairs as necessary
- Work with Regulatory Leadership to identify membership needs and develop Board members
- Promote accountability through motivation, team building, training, mentoring, collaboration, and respect
Requirements
What you’ll need- Bachelor’s Degree
- One (1)+ years of IRB or Clinical Research Industry experience preferred, OR minimum 3 years’ experience in healthcare within the last 6 years
- Strong understanding of research regulations and guidance
- Master’s Degree preferred
- Certified IRB Professional (CIP) certification preferred
- Ability to learn and comprehend basic instructions
- Ability to focus and attend to tasks and responsibilities
- Verbal communication, listening and understanding, responding, and speaking
- Ability to sit or stand for extended periods at a stationary workstation
- Ability to regularly carry, raise, and lower objects of up to 10 lbs.
- Candidates must work remotely in the United States
Benefits
Comp & perks- Variable bonus eligibility in addition to base salary
- Health coverage
- Paid holidays
- Inclusive and collaborative workplace culture
- Equal opportunity workplace
