Clinical Research Coordinators

Agriculture, Food & Natural Resources > Natural Resources Systems

Projected Growth: Average

6100+
Projected Job Openings

Considerable Preparation Needed

Job Description

Your job is to 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.

Common job titles of Clinical Research Coordinators include:
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Experience and Education

A considerable amount of work-related skill, knowledge, or experience is needed for this occupation. For example, a person in this occupation must complete four years of college and work for several years in industry to be considered qualified.

  • 55.54% said they needed a Bachelor's Degree.

  • 12.22% said they needed a Master's Degree.

Tasks

    Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.

    Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with physicians and nurses.

    Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.

    Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.

    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.

    Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.

    Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.

    Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.

    Communicate with laboratories or investigators regarding laboratory findings.

    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.

    Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.

    Participate in preparation and management of research budgets and monetary disbursements.

    Register protocol patients with appropriate statistical centers as required.

    Arrange for research study sites and determine staff or equipment availability.

    Code, evaluate, or interpret collected study data.

    Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.

    Direct the requisition, collection, labeling, storage, or shipment of specimens.

    Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts, such as protocol revisions.

    Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.

    Organize space for study equipment and supplies.

    Order drugs or devices necessary for study completion.

    Participate in the development of study protocols including guidelines for administration or data collection procedures.

    Prepare study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

    Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.

    Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, or potential subject risks.

    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.

    Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.

    Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.

    Solicit industry-sponsored trials through contacts and professional organizations.

    Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

Tools

Smartphones

Photocopiers

Personal computers

Laser facsimile machines

Laptop computers

Digital video equipment

Technologies

IBM SPSS Statistics

5AM Glassbox Translational Research

Budgeting software

ClearTrial

Clinical data management system CDMS

Drug coding software

DZS Software Solutions ClinPlus

All Technologies

Electronic data capture EDC software

ePharmaSolutions eMVR

FileMaker Pro

InferMed MACRO Electronic Data Capture

InforSense InforSense

Invivo Data EPX ePRO Management System

KIKA Veracity

Online data collection systems

OpenClinica

Oracle Clinical

Patient tracking software

PercipEnz Technologies OnCore-Clinical Research Management OnCore-CRM

Phase Forward InForm GTM

PPD eLoader

PPD Patient Profiles

Project management software

Qualitative analysis software

Scheduling software

Sierra Scientific Software CRIS

StudyManager Sponsor Edition

SyMetric Sciences SyMetric

TOPAZ Enterprise Software Suite

Skills

Reading Comprehension

Understanding written sentences and paragraphs in work related documents.

Active Listening

Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.

Writing

Communicating effectively in writing as appropriate for the needs of the audience.

Coordination

Adjusting actions in relation to others' actions.

Speaking

Talking to others to convey information effectively.

Critical Thinking

Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.

Monitoring

Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.

Judgment and Decision Making

Considering the relative costs and benefits of potential actions to choose the most appropriate one.

Time Management

Managing one's own time and the time of others.

Management of Personnel Resources

Motivating, developing, and directing people as they work, identifying the best people for the job.

Social Perceptiveness

Being aware of others' reactions and understanding why they react as they do.

Complex Problem Solving

Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.

Active Learning

Understanding the implications of new information for both current and future problem-solving and decision-making.

Service Orientation

Actively looking for ways to help people.

Persuasion

Persuading others to change their minds or behavior.

Negotiation

Bringing others together and trying to reconcile differences.

Instructing

Teaching others how to do something.

Learning Strategies

Selecting and using training/instructional methods and procedures appropriate for the situation when learning or teaching new things.

Abilities

Listen to and understand information and ideas presented through spoken words and sentences.

Cognitive Abilities › Verbal Abilities › Oral Comprehension

Read and understand information and ideas presented in writing.

Cognitive Abilities › Verbal Abilities › Written Comprehension

Communicate information and ideas in speaking so others will understand.

Cognitive Abilities › Verbal Abilities › Oral Expression

Communicate information and ideas in writing so others will understand.

Cognitive Abilities › Verbal Abilities › Written Expression

Tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.

Cognitive Abilities › Idea Generation and Reasoning Abilities › Problem Sensitivity

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Occupation Sections

Knowledge

Medicine and Dentistry

Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.

English Language

Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

Administration and Management

Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.

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