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