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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 clinical research, with a strong understanding of biological and pharmacological sciences. Capable of effective communication and collaboration with stakeholders in the Institutional Review Board process.
Highest-signal resume keywords
Regulatory ComplianceClinical Research ExperienceBiological Sciences KnowledgeVerbal CommunicationTeam Building
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 KnowledgeIRB Review ProcessSubmission ReviewProtocol PresentationScientific Knowledge
Soft Skills
Problem SolvingAttention to DetailMotivationCollaborationMentoring
Industry Keywords
Clinical ResearchHealthcareBoard Standard Operating ProceduresOrganizational PoliciesCRO Consultation
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 review activities while preserving professionalism and regulatory compliance
- Answer questions and solve day-to-day challenges using scientific knowledge and regulatory expertise
- 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 for guidance, inconsistencies in Board reviews, and related issues to senior regulatory staff
- Consult with sponsors, investigators, and CROs on clinical and regulatory affairs
- 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 biological and/or pharmacological sciences through education or experience
- 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.
- Ability to learn and comprehend basic instructions
- Focus and attention to tasks and responsibilities
- Verbal communication; listening and understanding, responding, and speaking
Benefits
Comp & perks- Variable bonus eligibility
- Health coverage
- Paid holidays
