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