Will “Development Associate” 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
- 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 “Development Associate”
- Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
- Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
- Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
- Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
- 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.
- Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
- Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
- 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.
- Develop advertising and other informational materials to be used in subject recruitment.
- Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
- Contact outside health care providers and communicate with subjects to obtain follow-up information.
- Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
- Arrange for research study sites and determine staff or equipment availability.
- Communicate with laboratories or investigators regarding laboratory findings.
- Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
- 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.
- Confer with health care professionals to determine the best recruitment practices for studies.
- 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.
- Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
- Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.
- Code, evaluate, or interpret collected study data.
- Inform patients or caregivers about study aspects and outcomes to be expected.
- Register protocol patients with appropriate statistical centers as required.
- Participate in preparation and management of research budgets and monetary disbursements.
- Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
- Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- Direct the requisition, collection, labeling, storage, or shipment of specimens.
- Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.
- Organize space for study equipment and supplies.
Related Technology & Tools
- Smartphones
- Laser facsimile machines
- Digital video equipment
- Personal computers
- Laptop computers
- Photocopiers
- InferMed MACRO Electronic Data Capture
- InforSense InforSense
- Patient tracking software
- OpenClinica
- Invivo Data EPX ePRO Management System
- Scheduling software
- The MathWorks MATLAB
- Oracle Clinical
- SPSS
- Project management software
- PPD eLoader
- SAS
- Microsoft Word
- 5AM Glassbox Translational Research
- ClearTrial
- Qualitative analysis software
- Microsoft Outlook
- PercipEnz Technologies OnCore-Clinical Research Management OnCore-CRM
- StataCorp Stata
- Budgeting software
- ePharmaSolutions eMVR
- DZS Software Solutions ClinPlus
- FileMaker Pro
- Clinical data management system CDMS
- Drug coding software
- Microsoft Excel
- Sierra Scientific Software CRIS
- Microsoft Office
- Microsoft Project
- Electronic data capture EDC software
- TOPAZ Enterprise Software Suite
- StudyManager Sponsor Edition
- Web browser software
- Microsoft PowerPoint
- Microsoft Access
- SyMetric Sciences SyMetric
- Phase Forward InForm GTM
- KIKA Veracity
- Online data collection systems
- PPD Patient Profiles