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