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