Operational Performer
CLIN.GEN.P2
Independently executes site management tasks and ensures adverse events and safety data are reported per protocol.
Independently executes site management tasks and ensures adverse events and safety data are reported per protocol.
The story of this role
Who does this work
A Clinical Research Coordinator who wants to design and conduct successful clinical trials that advance medical science and improve patient lives.
The problem this role solves
- The external problem: There is increasing competition in the pharmaceutical industry, making it necessary to develop innovative approaches to clinical trials.
- The internal problem: The coordinator often feels overwhelmed by the complexity of regulatory requirements and the need for effective communication within study teams.
- Why it matters: Every patient deserves access to safe and effective treatments available through rigorous scientific evaluation.
The plan
- 1. Develop a comprehensive study protocol that outlines objectives and methodology.
- 2. Assemble a diverse team of experts across disciplines, including clinical staff, data managers, and regulatory specialists.
- 3. Prepare and submit all necessary documents to regulatory authorities for approval.
- 4. Recruit and screen eligible participants, ensuring their needs and rights are prioritized throughout the process.
- 5. Monitor trials diligently to ensure compliance, collect data accurately, and analyze results to establish safety and efficacy.
What's at stake
1. Encounter significant delays or failures in trials due to poor planning or insufficient resources. 2. Risk the safety of participants and the integrity of the research due to lack of adherence to protocols or regulations.
Success looks like
1. Successfully lead clinical trials that result in new drugs or devices receiving regulatory approval. 2. Achieve recognition for the team’s work, contributing to improved patient outcomes and advancing medical knowledge.
Summary
Independently executes site management tasks and ensures adverse events and safety data are reported per protocol.
Level — P2 — Developing Professional
Early-career professional; developing skills, handles routine tasks with some independence
- Scope
- Defined deliverables / small features
- Autonomy
- General supervision; reviewed at milestones
- Complexity
- Some non-routine problems; applies established patterns
- Impact
- Own and immediate-team deliverables
- Decision rights
- Routine technical choices within guidance
- Leadership
- May guide interns
- Typical experience
- 1–3 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
- Conducts site initiation, routine monitoring, and close-out visitscommonlevel
- Verifies source data against CRFs to ensure accuracycommonlevel
- Maintains regulatory documentscommonlevel
- Reports adverse events and safety datacommonlevel
- Ensures site compliance with protocolscommonlevel
Tasks3
- Conduct site visitscommonlevel
- Verify data accuracycommonlevel
- Maintain regulatory compliancecommonlevel
Skills5
- Site managementcommonlevel
- Data verificationcommonlevel
- Regulatory documentationcommonlevel
- Communicationcommonlevel
- Problem-solvingcommonlevel
Knowledge5
- Clinical trial monitoringcommonlevel
- Regulatory documentationcommonlevel
- Adverse event reportingcommonlevel
- CRF data verificationcommonlevel
- Site management processescommonlevel
competency5
- Effective problem solvingcommonlevel
- Organizational skillscommonlevel
- Proactive communicationcommonlevel
- Regulatory adherencecommonlevel
- Data verificationcommonlevel
qualification2
- Bachelor’s or Master’s in clinical research, pharmacy, biology, nursing, or equivalentcommonlevel
- Certifications such as CCRA, CCRP, or CIPcommonlevel
Title aliasesshow ▾
| Alias | Type | Confidence | Approved |
|---|---|---|---|
| Clinical Research II | common | medium0.70 | — |
| Clinical Research 2 | common | medium0.66 | — |
| Operational Performer | common | medium0.50 | — |
Classification mappingsshow ▾
O*NET / SOC
- code=19-0000title=Life, Physical, & Social Science Occupationssource=inferred_from_superfunctionreviewStatus=needs_review