Will “Clinical Research Associate (CRA)” be Replaced By Robots? 🤔
Unknown Chance of Automation
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Job Description
Plan, direct, or coordinate clinical research projects. Direct the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives. May evaluate and analyze clinical data.
Job Details
- The SOC (Standard Occupational Classification) code is 11-9121.01
☝️ Information based on the reference occupation “Clinical Research Coordinators”.
Also Known As…
- Clinical Research Coordinators
- Research Coordinator
- Clinical Trial Manager
- Clinical Trial Coordinator
- Clinical Research Nurse Coordinator
- Clinical Research Manager
- Clinical Research Coordinator
- Clinical Research Associate (CRA)
- Clinical Research Administrator
- Clinical Program Manager
- Clinical Program Coordinator
- Research Associate
- Regulatory Coordinator
- Development Coordinator
- Development Associate
- Clinical Trials Specialist
- Clinical Trials Manager
- Clinical Trial Associate
- Clinical Support Specialist
- Clinical Study Manager
- Clinical Researcher
- Clinical Research Specialist
- Clinical Research Monitor
- Clinical Research Director
- Clinical Research Assistant
- Clinical Project Manager
- Clinical Operations Specialist
- Clinical Manager
- Clinical Data Coordinator
Tasks for “Clinical Research Associate (CRA)”
- Contact outside health care providers and communicate with subjects to obtain follow-up information.
- Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.
- Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
- Arrange for research study sites and determine staff or equipment availability.
- Participate in the development of study protocols including guidelines for administration or data collection procedures.
- Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
- Develop advertising and other informational materials to be used in subject recruitment.
- Organize space for study equipment and supplies.
- Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
- Inform patients or caregivers about study aspects and outcomes to be expected.
- Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
- Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
- Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
- Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
- Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
- Communicate with laboratories or investigators regarding laboratory findings.
- Code, evaluate, or interpret collected study data.
- Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
- Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
- Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
- Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.
- Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
- Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
- Solicit industry-sponsored trials through contacts and professional organizations.
- Participate in preparation and management of research budgets and monetary disbursements.
- Direct the requisition, collection, labeling, storage, or shipment of specimens.
- Order drugs or devices necessary for study completion.
- Confer with health care professionals to determine the best recruitment practices for studies.
- Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
- Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
- Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- Register protocol patients with appropriate statistical centers as required.
- Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
Related Technology & Tools
- Digital video equipment
- Smartphones
- Personal computers
- Photocopiers
- Laptop computers
- Laser facsimile machines
- FileMaker Pro
- Oracle Clinical
- Microsoft Outlook
- InforSense InforSense
- Patient tracking software
- 5AM Glassbox Translational Research
- SPSS
- InferMed MACRO Electronic Data Capture
- Scheduling software
- TOPAZ Enterprise Software Suite
- Electronic data capture EDC software
- SyMetric Sciences SyMetric
- Microsoft Excel
- Clinical data management system CDMS
- Invivo Data EPX ePRO Management System
- Microsoft Office
- The MathWorks MATLAB
- Budgeting software
- Online data collection systems
- Sierra Scientific Software CRIS
- Phase Forward InForm GTM
- Web browser software
- Drug coding software
- Microsoft PowerPoint
- ePharmaSolutions eMVR
- Microsoft Word
- Microsoft Access
- Project management software
- Qualitative analysis software
- ClearTrial
- PPD eLoader
- PPD Patient Profiles
- SAS
- KIKA Veracity
- DZS Software Solutions ClinPlus
- Microsoft Project
- OpenClinica
- StudyManager Sponsor Edition
- StataCorp Stata
- PercipEnz Technologies OnCore-Clinical Research Management OnCore-CRM