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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in technical and medical writing, particularly in editing consent forms to ensure regulatory compliance. Possesses strong communication skills and a thorough understanding of human subjects research and informed consent processes.
Highest-signal resume keywords
Technical WritingEditing Consent FormsHuman Subjects Research TrainingRegulatory ComplianceAttention to Detail
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Technical WritingEditingRegulatory ComplianceMedical TerminologyDocument ReviewProject ManagementInformed ConsentWord ProcessingEditing FunctionsClinical Research
Soft Skills
Clear CommunicationProblem-SolvingAttention to DetailIndependenceCollaboration
Tools & Technologies
Microsoft ExcelMicrosoft PowerPointSlackZoomRingCentralWeb-Based Software
Certifications & Qualifications
CITI Training
Industry Keywords
Human Subject ProtectionsResearch ComplianceStakeholder CollaborationClinical ResearchInformed Consent
About the role
Key responsibilities & impact- Conduct accurate pre-reviews of new and revised consent forms for regulatory compliance
- Edit consent forms to align with regulatory standards and Advarra document requirements
- Incorporate negotiated Sponsor language into consent forms according to client agreements
- Collaborate with Board members and staff to incorporate stakeholder edits
- Maintain and enhance knowledge of U.S. and/or Canadian regulations and guidelines related to human subject protections and research
- Complete recurring Human Subjects Research Training, such as CITI
- Attend at least one IRB meeting per month, or two per month during initial training
- Suggest process improvements to management
- Fulfill organizational training requirements
- Perform other assigned duties
Requirements
What you’ll need- 1+ years of experience in technical/medical writing and/or editing
- Bachelor’s degree
- Experience writing and/or editing consent forms or other research documents
- Proficiency in word processing and editing, including Tracked Changes and Compare Merge functions
- Familiarity with Excel, PowerPoint, Slack or similar direct messaging applications, Zoom or RingCentral or similar remote meeting applications, and web-based proprietary software
- Ability to communicate clearly and professionally in English, verbally and in writing
- Some clinical research experience preferred
- Knowledge of human subjects research and informed consent
- Familiarity with scientific/medical terminology and ability to convert scientific/medical information to lay terms
- Ability to edit technical and/or medical documents
- Ability to read and comprehend advanced technical/medical documents
- Ability to manage various editing projects under conflicting demands and priorities
- High level of attention to detail, accuracy, thoroughness, and problem-solving skills
- Ability to follow written and verbal instructions and work independently
- Completion of recurring Human Subjects Research Training, such as CITI
- Completion of organizational training requirements
- Ability to meet physical and mental requirements, including sitting or standing for extended periods, carrying objects up to 10 lbs., learning basic instructions, focusing on tasks, and verbal communication
Benefits
Comp & perks- Variable bonus eligibility
- Health coverage
- Paid holidays
- Other benefits
- Remote work arrangement