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