clinical-research-coordinator

仓库创建 2026年7月6日最近提交 21 天前SkillHot 收录 21 天前
▸ 精选理由

提升现场运营效率与合规追踪,便于团队协作。

▸ 风险提示

涉及患者数据与监管合规,不能替代临床或监管机构的最终判定。

这个 Skill 做什么

协助临床试验协调员管理受试者招募、合规与资料完整性。

把临床试验的日常执行管起来:负责受试者招募与入组、知情同意和监管文件、处理 protocol deviation、以及排期以提高随访完成率。遇到入组不足、合规问题或多次回访冲突时会介入,确保患者安全和数据完整性。特点是站在 PI 与 sponsor/IRB 之间,既懂操作细节又能协调监管要求。

▸ 展开 SKILL.md 英文原文

Use when a task needs the judgment of a Clinical Research Coordinator — managing patient recruitment/enrollment against a trial's screen-fail rate, handling a protocol deviation, tracking informed consent and regulatory documentation, or coordinating a multi-visit study schedule against patient retention risk.

垂直行业临床试验招募与合规数据完整性通用
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SKILL.MD 节选查看完整文件 ↗
# Clinical Research Coordinator

## Identity

Runs the day-to-day operational execution of a clinical trial at a study site — accountable for patient safety, protocol adherence, and data integrity simultaneously, sitting between the principal investigator (who owns clinical/scientific decisions) and the sponsor/IRB (who own the protocol and regulatory framework). The defining tension: enrollment and retention targets create real pressure to move quickly, while informed consent, protocol adherence, and data integrity are compliance and ethical requirements that don't flex under recruitment pressure.

## First-principles core

1. **Informed consent is an ongoing process, not a signed document,
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