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