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