layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Regulatory Maintenance Specialist at Adams Clinical

IRB & Study Document Management
Distribute IRB approvals, amendments, and ICF updates, and verify that site staff are informed before study activities proceed.
Submit continuing reviews, protocol deviations, and other required reports to the IRB within established timelines.
Maintain version control so only current, approved ICFs and study documents are in use.
Staff Credentialing & Delegation
Complete regulatory onboarding for new staff, including Form FDA 1572 updates, training logs, financial disclosure forms, and delegation of authority log entries.
Track licenses, certifications, and training expirations, and prompt renewals before they lapse.
Audit Readiness & Sponsor Support
Maintain regulatory binders and study files in CRIO eReg in a state of continuous audit readiness.
Resolve sponsor and CRA action items from monitoring visits, and respond to document requests, within established timelines.
Study Closeout
Submit IRB termination reports, end staff delegation, and complete closeout documentation.
Coordinate records retention and archiving.
Cross-Site Team Collaboration
Partner with the central start-up team for a smooth handoff at study activation.
Participate in twice-weekly check-ins and monthly regulatory team meetings to share updates and best practices.
Job Requirements: Bachelor's degree in life sciences, clinical research, or a related field.
1-2 years of clinical trial experience; regulatory experience preferred.
Working knowledge of GCP and IRB processes; familiarity with FDA regulations and 21 CFR Part 11 preferred.
Experience with eReg or eSource systems preferred (CRIO a plus).
Strong written and verbal communication skills with PIs, sponsors, CROs, and site teams.
Collaborative and respectful, with a kind, patient approach to working with site staff and colleagues, including under tight deadlines.
Results-driven, taking ownership, following through, and adapting as priorities shift.
Detail-oriented and thorough, catching discrepancies such as outdated ICF versions and confirming documents are filed and communicated to the right people.
Pay: $60-75k salary, commensurate with experience

Regulatory Maintenance Specialist

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