CLINICAL RESEARCH COORDINATOR "D"

Role of CRC

CLINICAL RESEARCH COORDINATOR Roles & Responsibilities 1) Participate in preparation and management of research budgets and monetary disbursements. 2) Inform patients or caregivers about study aspects and outcomes to be expected. 3) Code, evaluate, or interpret collected study data. 4) Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. 5) Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms. 6) Communicate with laboratories or investigators regarding laboratory findings. 7) Solicit industry-sponsored trials through contacts and professional organizations. 8) Order drugs or devices necessary for study completion. 9) Direct the requisition, collection, labelling, storage, or shipment of specimens. 10) Arrange for research study sites and determine staff or equipment availability. 11) Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues. 12) Register protocol patients with appropriate statistical centres as required. 13) Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. 14) Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms. 15) Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics. 16) Develop advertising and other informational materials to be used in subject recruitment. 17) Contact industry representatives to ensure equipment and software specifications necessary for successful study completion. 18) Confer with health care professionals to determine the best recruitment practices for studies. 19) Organize space for study equipment and supplies. 20) Track enrolment status of subjects and document dropout information such as dropout causes and subject contact efforts. 21) Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. 22) Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies. 23) Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. 24) Participate in the development of study protocols including guidelines for administration or data collection procedures. 25) Oversee subject enrolment to ensure that informed consent is properly obtained and documented. 26) Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data. 27) Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures. 28) Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions. 29) Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary. 30) Contact outside health care providers and communicate with subjects to obtain follow-up information. 31) Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions. 32) Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. 33) Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols. Activities 1) Getting Information -- Observing, receiving, and otherwise obtaining information from all relevant sources. 2) Establishing and Maintaining Interpersonal Relationships -- Developing constructive and cooperative working relationships with others, and maintaining them over time. 3) Making Decisions and Solving Problems -- Analyzing information and evaluating results to choose the best solution and solve problems. 4) Organizing, Planning, and Prioritizing Work -- Developing specific goals and plans to prioritize, organize, and accomplish your work. 5) Updating and Using Relevant Knowledge -- Keeping up-to-date technically and applying new knowledge to your job. 6) Communicating with Supervisors, Peers, or Subordinates -- Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person. 7) Documenting/Recording Information -- Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form. 8) Processing Information -- Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data. 9) Scheduling Work and Activities -- Scheduling events, programs, and activities, as well as the work of others. 10) Interacting With Computers -- Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information. 11) Evaluating Information to Determine Compliance with Standards -- Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards. 12) Identifying Objects, Actions, and Events -- Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events. Abilities 1) Written Comprehension -- The ability to read and understand information and ideas presented in writing. 2) Oral Expression -- The ability to communicate information and ideas in speaking so others will understand. 3) Oral Comprehension -- The ability to listen to and understand information and ideas presented through spoken words and sentences. 4) Written Expression -- The ability to communicate information and ideas in writing so others will understand. 5) Speech Recognition -- The ability to identify and understand the speech of another person. 6) Deductive Reasoning -- The ability to apply general rules to specific problems to produce answers that make sense. 7) Inductive Reasoning -- The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events). 8) 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 there is a problem. 9) Speech Clarity -- The ability to speak clearly so others can understand you. 10) Near Vision -- The ability to see details at close range (within a few feet of the observer). 11) 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). 12) Category Flexibility -- The ability to generate or use different sets of rules for combining or grouping things in different ways. 13) Selective Attention -- The ability to concentrate on a task over a period of time without being distracted. 14) 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). 15) 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. Knowledge /Education/Experience 1) 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. 2) English Language -- Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar. 3) Administration and Management -- Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modelling, leadership technique, production methods, and coordination of people and resources. Skills 1) Reading Comprehension -- Understanding written sentences and paragraphs in work related documents. 2) 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. 3) Writing -- Communicating effectively in writing as appropriate for the needs of the audience. 4) Coordination -- Adjusting actions in relation to others' actions. 5) Speaking -- Talking to others to convey information effectively. 6) Critical Thinking -- Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. 7) Monitoring -- Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action. 8) Judgement and Decision Making -- Considering the relative costs and benefits of potential actions to choose the most appropriate one. 9) Time Management -- Managing one's own time and the time of others. 10) Management of Personnel Resources -- Motivating, developing, and directing people as they work, identifying the best people for the job. 11) Social Perceptiveness -- Being aware of others' reactions and understanding why they react as they do. 12) Complex Problem Solving -- Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.

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