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