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