Clinical Research Coordinator 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.
Clinical Research Coordinator is Also Know as
In different settings, Clinical Research Coordinator is titled as
- Clinical Coordinator
- Clinical Program Coordinator
- Clinical Program Manager
- Clinical Research Administrator
- Clinical Research Coordinator
- Clinical Research Manager
- Clinical Research Nurse Coordinator
- Clinical Trial Coordinator
- Clinical Trial Manager
- Research Coordinator
Education and Training of Clinical Research Coordinator
Clinical Research Coordinator is categorized in Job Zone Four: Considerable Preparation Needed
Experience Required for Clinical Research Coordinator
A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.
Education Required for Clinical Research Coordinator
Most of these occupations require a four-year bachelor's degree, but some do not.
Degrees Related to Clinical Research Coordinator
- Bachelor in Engineering Physics/Applied Physics
- Associate Degree Courses in Engineering Physics/Applied Physics
- Masters Degree Courses in Engineering Physics/Applied Physics
- Bachelor in Operations Research
- Associate Degree Courses in Operations Research
- Masters Degree Courses in Operations Research
- Bachelor in Biology/Biological Sciences, General
- Associate Degree Courses in Biology/Biological Sciences, General
- Masters Degree Courses in Biology/Biological Sciences, General
- Bachelor in Biochemistry
- Associate Degree Courses in Biochemistry
- Masters Degree Courses in Biochemistry
- Bachelor in Biophysics
- Associate Degree Courses in Biophysics
- Masters Degree Courses in Biophysics
- Bachelor in Molecular Biology
- Associate Degree Courses in Molecular Biology
- Masters Degree Courses in Molecular Biology
Training Required for Clinical Research Coordinator
Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
Related Ocuupations
Some Ocuupations related to Clinical Research Coordinator in different industries are
- Clinical Data Managers
- Health Informatics Specialists
- Clinical Nurse Specialists
- Health Specialties Teachers, Postsecondary
- Medical and Health Services Managers
- Natural Sciences Managers
- Medical and Clinical Laboratory Technologists
- Social Science Research Assistants
- Medical Scientists, Except Epidemiologists
- Water Resource Specialists
- Health Information Technologists and Medical Registrars
- Epidemiologists
- Patient Representatives
- Clinical Neuropsychologists
- Health Education Specialists
- Biostatisticians
- Medical and Clinical Laboratory Technicians
- Data Scientists
- Regulatory Affairs Specialists
- Cardiovascular Technologists and Technicians
What Do Clinical Research Coordinator do?
- Solicit industry-sponsored trials through contacts and professional organizations.
- Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
- 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.
- Participate in preparation and management of research budgets and monetary disbursements.
- Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
- Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
- Develop advertising and other informational materials to be used in subject recruitment.
- Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.
- Confer with health care professionals to determine the best recruitment practices for studies.
- Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
- Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, or potential subject risks.
- Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
- Prepare study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
- Participate in the development of study protocols including guidelines for administration or data collection procedures.
- Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
- Order drugs or devices necessary for study completion.
- Organize space for study equipment and supplies.
- Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
- Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
- Inform patients or caregivers about study aspects and outcomes to be expected.
- Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts, such as protocol revisions.
- Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.
- Direct the requisition, collection, labeling, storage, or shipment of specimens.
- Contact outside health care providers and communicate with subjects to obtain follow-up information.
- Communicate with laboratories or investigators regarding laboratory findings.
- Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
- Code, evaluate, or interpret collected study data.
- Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with physicians and nurses.
- Arrange for research study sites and determine staff or equipment availability.
- Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
- Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
- Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
Qualities of Good Clinical Research Coordinator
- Written Comprehension: The ability to read and understand information and ideas presented in writing.
- Oral Expression: The ability to communicate information and ideas in speaking so others will understand.
- Written Expression: The ability to communicate information and ideas in writing so others will understand.
- Oral Comprehension: The ability to listen to and understand information and ideas presented through spoken words and sentences.
- Problem Sensitivity: The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing that there is a problem.
- Deductive Reasoning: The ability to apply general rules to specific problems to produce answers that make sense.
- Inductive Reasoning: The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
- Information Ordering: The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
- Speech Clarity: The ability to speak clearly so others can understand you.
- Speech Recognition: The ability to identify and understand the speech of another person.
- Near Vision: The ability to see details at close range (within a few feet of the observer).
- Category Flexibility: The ability to generate or use different sets of rules for combining or grouping things in different ways.
- Mathematical Reasoning: The ability to choose the right mathematical methods or formulas to solve a problem.
- Fluency of Ideas: The ability to come up with a number of ideas about a topic (the number of ideas is important, not their quality, correctness, or creativity).
- Far Vision: The ability to see details at a distance.
- Perceptual Speed: The ability to quickly and accurately compare similarities and differences among sets of letters, numbers, objects, pictures, or patterns. The things to be compared may be presented at the same time or one after the other. This ability also includes comparing a presented object with a remembered object.
- Number Facility: The ability to add, subtract, multiply, or divide quickly and correctly.
- Flexibility of Closure: The ability to identify or detect a known pattern (a figure, object, word, or sound) that is hidden in other distracting material.
- Selective Attention: The ability to concentrate on a task over a period of time without being distracted.
- Time Sharing: The ability to shift back and forth between two or more activities or sources of information (such as speech, sounds, touch, or other sources).
- Originality: The ability to come up with unusual or clever ideas about a given topic or situation, or to develop creative ways to solve a problem.
- Speed of Closure: The ability to quickly make sense of, combine, and organize information into meaningful patterns.
- Visualization: The ability to imagine how something will look after it is moved around or when its parts are moved or rearranged.
- Memorization: The ability to remember information such as words, numbers, pictures, and procedures.
- Auditory Attention: The ability to focus on a single source of sound in the presence of other distracting sounds.
- Visual Color Discrimination: The ability to match or detect differences between colors, including shades of color and brightness.
- Finger Dexterity: The ability to make precisely coordinated movements of the fingers of one or both hands to grasp, manipulate, or assemble very small objects.
- Hearing Sensitivity: The ability to detect or tell the differences between sounds that vary in pitch and loudness.
- Depth Perception: The ability to judge which of several objects is closer or farther away from you, or to judge the distance between you and an object.
- Trunk Strength: The ability to use your abdominal and lower back muscles to support part of the body repeatedly or continuously over time without "giving out" or fatiguing.
- Wrist-Finger Speed: The ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Dynamic Strength: The ability to exert muscle force repeatedly or continuously over time. This involves muscular endurance and resistance to muscle fatigue.
- Spatial Orientation: The ability to know your location in relation to the environment or to know where other objects are in relation to you.
- Extent Flexibility: The ability to bend, stretch, twist, or reach with your body, arms, and/or legs.
- Rate Control: The ability to time your movements or the movement of a piece of equipment in anticipation of changes in the speed and/or direction of a moving object or scene.
- Arm-Hand Steadiness: The ability to keep your hand and arm steady while moving your arm or while holding your arm and hand in one position.
- Sound Localization: The ability to tell the direction from which a sound originated.
- Manual Dexterity: The ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.
- Control Precision: The ability to quickly and repeatedly adjust the controls of a machine or a vehicle to exact positions.
- Glare Sensitivity: The ability to see objects in the presence of a glare or bright lighting.
- Multilimb Coordination: The ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting, standing, or lying down. It does not involve performing the activities while the whole body is in motion.
- Peripheral Vision: The ability to see objects or movement of objects to one's side when the eyes are looking ahead.
- Night Vision: The ability to see under low-light conditions.
- Response Orientation: The ability to choose quickly between two or more movements in response to two or more different signals (lights, sounds, pictures). It includes the speed with which the correct response is started with the hand, foot, or other body part.
- Speed of Limb Movement: The ability to quickly move the arms and legs.
- Reaction Time: The ability to quickly respond (with the hand, finger, or foot) to a signal (sound, light, picture) when it appears.
- Gross Body Equilibrium: The ability to keep or regain your body balance or stay upright when in an unstable position.
- Gross Body Coordination: The ability to coordinate the movement of your arms, legs, and torso together when the whole body is in motion.
- Dynamic Flexibility: The ability to quickly and repeatedly bend, stretch, twist, or reach out with your body, arms, and/or legs.
- Stamina: The ability to exert yourself physically over long periods of time without getting winded or out of breath.
- Explosive Strength: The ability to use short bursts of muscle force to propel oneself (as in jumping or sprinting), or to throw an object.
- Static Strength: The ability to exert maximum muscle force to lift, push, pull, or carry objects.
Tools Used by Clinical Research Coordinator
- Digital video equipment
- Laptop computers
- Laser facsimile machines
- Personal computers
- Photocopiers
- Smartphones
Technology Skills required for Clinical Research Coordinator
- 5AM Glassbox Translational Research
- Budgeting software
- ClearTrial
- Clinical data management system CDMS
- Drug coding software
- DZS Software Solutions ClinPlus
- Electronic data capture EDC software
- ePharmaSolutions eMVR
- FileMaker Pro
- Google Meet
- IBM SPSS Statistics
- InferMed MACRO Electronic Data Capture
- InforSense InforSense
- Invivo Data EPX ePRO Management System
- KIKA Veracity
- Microsoft Access
- Microsoft Excel
- Microsoft Office software
- Microsoft Outlook
- Microsoft PowerPoint
- Microsoft Project
- Microsoft Word
- Minitab
- 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
- Python
- Qualitative analysis software
- R
- SAS
- Scheduling software
- Sierra Scientific Software CRIS
- StataCorp Stata
- StudyManager Sponsor Edition
- SyMetric Sciences SyMetric
- The MathWorks MATLAB
- TOPAZ Enterprise Software Suite
- Web browser software