Entry Support
CORD.GEN.P1
Clinical Trials Coordinator / Administrator / Associate
Clinical Trials Coordinator / Administrator / Associate
The story of this role
Who does this work
A Clinical Operations professional passionate about advancing healthcare through effective clinical trials and seeking to ensure the success of new therapies.
The problem this role solves
- The external problem: Clinical trials are often delayed or fail due to poor design, inadequate site selection, or lack of compliance with protocols.
- The internal problem: The worker feels overwhelmed by the complexity of managing multiple trials while ensuring compliance and reliability of data.
- Why it matters: Every patient deserves access to safe and effective therapies, and it's frustrating when procedural setbacks hinder medical advancements.
The plan
- Conduct thorough research to understand trial requirements and regulatory standards.
- Collaborate with multidisciplinary teams for effective site selection and trial design.
- Implement robust project management strategies to keep trials on schedule and within budget.
- Ensure continuous communication with all stakeholders throughout the trial process.
- Facilitate comprehensive training for site staff to ensure adherence to protocols.
What's at stake
Trials fall behind schedule and exceed budget, jeopardizing the introduction of new therapies. Inadequate compliance leads to unreliable data, resulting in failed regulatory submissions and wasted resources.
Success looks like
Clinical trials are completed on time and within budget, leading to the successful launch of new therapies. Reliable data is generated, enhancing regulatory approval processes and improving patient outcomes.
Summary
Clinical Trials Coordinator / Administrator / Associate
Level — P1 — Entry-Level Professional
New to role or field; performs basic tasks under supervision
- Scope
- Own tasks within a defined component
- Autonomy
- Close supervision; work reviewed frequently
- Complexity
- Routine problems with known solutions
- Impact
- Own deliverables
- Decision rights
- Few independent decisions; escalates the rest
- Leadership
- None — building the craft
- Typical experience
- 0–2 yrs
Core outputs
No core outputs recorded yet.
Adjacent roles
Nearest roles by structural coordinates (level + taxonomy). Distance 0 → 1; each carries its 3-state match band. How coordinates work → · Compare side-by-side →
Componentsshow ▾
Responsibilities5
- Support trial logistics: prepare site documents, maintain regulatory binders, and set up study in CTMS.commonlevel
- Assist with IRB submissions, meeting coordination, and trial correspondence.commonlevel
- Perform data entry and quality checks under supervision; update trial trackers and issue logs.commonlevel
- Handle administrative tasks (ordering supplies, tracking shipments, scheduling meetings and monitors).commonlevel
- Participate in investigator meetings and provide trial status updates to the team.commonlevel
Tasks5
- Prepare and maintain trial documentationcommonlevel
- Coordinate trial logisticscommonlevel
- Perform data quality checkscommonlevel
- Assist in IRB submissionscommonlevel
- Update trial trackerscommonlevel
Skills8
- Document preparationcommonlevel
- Regulatory compliancecommonlevel
- Data entrycommonlevel
- Quality assurancecommonlevel
- Administrative supportcommonlevel
- Meeting coordinationcommonlevel
- CTMS proficiencycommonlevel
- MS Office proficiencycommonlevel
Knowledge8
- Clinical trial processescommonlevel
- Regulatory requirementscommonlevel
- GCP principlescommonlevel
- CTMS/EDC systemscommonlevel
- Trial documentationcommonlevel
- Data quality managementcommonlevel
- Basic clinical research conceptscommonlevel
- Administrative procedurescommonlevel
competency4
- Teamwork & Initiativecommonlevel
- Organizationcommonlevel
- Detail Orientationcommonlevel
- Communicationcommonlevel
qualification3
- Basic understanding of clinical research and GCP principles.commonlevel
- Familiarity with trial documentation and CTMS/EDC systems.commonlevel
- Proficiency in MS Office (Excel, Word).commonlevel
Title aliasesshow ▾
| Alias | Type | Confidence | Approved |
|---|---|---|---|
| Entry Support | common | medium0.50 | — |
Classification mappingsshow ▾
O*NET / SOC
- code=19-0000title=Life, Physical, & Social Science Occupationssource=inferred_from_superfunctionreviewStatus=needs_review