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