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