Job DescriptionJob Description
We are seeking a detail-oriented Clinical Research Regulatory & Source Document Specialist to support our growing clinical research team. This position is responsible for creating and maintaining source documents, reviewing protocol amendments, updating study materials, and ensuring research documentation remains accurate, organized, and compliant with sponsor and regulatory requirements.
The ideal candidate is highly organized, proactive, and experienced in clinical research documentation and protocol management.
Responsibilities
Create, update, and maintain study source documents for clinical trialsReview protocol amendments and identify required study changesUpdate source packets, visit worksheets, logs, and study tools following protocol revisionsEnsure all study documents remain compliant with sponsor, GCP, and site requirementsCommunicate protocol and amendment changes to research staff as neededAssist with study startup and ongoing document preparationSupport quality control efforts and audit readinessMaintain accurate filing and version control of study documentation
Qualifications
Clinical research experience preferredExperience reviewing protocols and amendments strongly preferredKnowledge of GCP, FDA regulations, and research documentation standardsStrong attention to detail and organizational skillsAbility to manage multiple studies and deadlines simultaneouslyProficient in Microsoft Office and electronic documentation systemsMedical terminology knowledge preferredCRC, regulatory, or research coordinator experience is a plus
Preferred Experience
Source document creationRegulatory coordinationProtocol review and implementationResearch quality assurance or quality controlSponsor and CRO communication
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