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