Will “Regulatory Coordinator” be Replaced By Robots? 🤔

Unknown Chance of Automation

Sadly, the research paper did not provide any information about this occupation. Maybe have a look at our directory?

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 “Regulatory Coordinator”

Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
Code, evaluate, or interpret collected study data.
Confer with health care professionals to determine the best recruitment practices for studies.
Order drugs or devices necessary for study completion.
Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
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.
Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
Participate in preparation and management of research budgets and monetary disbursements.
Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
Solicit industry-sponsored trials through contacts and professional organizations.
Contact outside health care providers and communicate with subjects to obtain follow-up information.
Develop advertising and other informational materials to be used in subject recruitment.
Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
Organize space for study equipment and supplies.
Direct the requisition, collection, labeling, storage, or shipment of specimens.
Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
Participate in the development of study protocols including guidelines for administration or data collection procedures.
Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
Register protocol patients with appropriate statistical centers as required.
Arrange for research study sites and determine staff or equipment availability.
Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.
Inform patients or caregivers about study aspects and outcomes to be expected.
Communicate with laboratories or investigators regarding laboratory findings.
Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.

Related Technology & Tools

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

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