Will “Clinical Operations Specialist” 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…

Tasks for “Clinical Operations Specialist”

Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.
Organize space for study equipment and supplies.
Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
Communicate with laboratories or investigators regarding laboratory findings.
Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
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.
Code, evaluate, or interpret collected study data.
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.
Develop advertising and other informational materials to be used in subject recruitment.
Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
Confer with health care professionals to determine the best recruitment practices for studies.
Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
Solicit industry-sponsored trials through contacts and professional organizations.
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.
Contact outside health care providers and communicate with subjects to obtain follow-up information.
Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
Participate in preparation and management of research budgets and monetary disbursements.
Inform patients or caregivers about study aspects and outcomes to be expected.
Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
Direct the requisition, collection, labeling, storage, or shipment of specimens.
Register protocol patients with appropriate statistical centers as required.
Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.
Arrange for research study sites and determine staff or equipment availability.
Participate in the development of study protocols including guidelines for administration or data collection procedures.

Related Technology & Tools

Laptop computers
Digital video equipment
Photocopiers
Laser facsimile machines
Personal computers
Smartphones

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5AM Glassbox Translational Research
Phase Forward InForm GTM
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Microsoft Project
SPSS
Invivo Data EPX ePRO Management System
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Microsoft Outlook
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Microsoft Office
Project management software
Sierra Scientific Software CRIS
InforSense InforSense
Web browser software
Oracle Clinical
The MathWorks MATLAB
Microsoft Access
SyMetric Sciences SyMetric
Microsoft Word
DZS Software Solutions ClinPlus
OpenClinica
StudyManager Sponsor Edition
InferMed MACRO Electronic Data Capture
Microsoft Excel
TOPAZ Enterprise Software Suite
ClearTrial
Patient tracking software
FileMaker Pro
ePharmaSolutions eMVR
PPD eLoader
PPD Patient Profiles
Microsoft PowerPoint
StataCorp Stata
SAS
Clinical data management system CDMS
Drug coding software