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