Clinical Research Assistant

Benefits

Qualifications

• •Strong written and oral communication skills
• •Excels at handling frequent task switching with efficiency
• •Ability to build effective relationships with trial center colleagues and staff
• •Superior problem solving, deductive reasoning and decision-making skills
• •Good time management and ability to prioritize tasks and accomplish set goals efficiently
• •Knowledge of statistical data collection, validation, editing and analysis techniques
• •Ability to provide technical guidance, advice and support to professional staff where needed
• •Knowledge of laboratory certification processes and standards
• •Excellent attention to detail and ability to maintain detailed and accurate records
• •Demonstrates a willingness to seek clarification without hesitation
• •Administrative Writing Skills
• •Microsoft Office Skills
• •Strong ability to organize workflows, schedules, and information efficiently
• •Professionalism, reliability, and strong interpersonal skills
• •Demonstrate knowledge of medical terminology
• •High school diploma or equivalent education required
• •Medical office and patient care experience required
• •Knowledge of appropriate software including Microsoft Word, Excel, Outlook, Microsoft PowerPoint, and Adobe Acrobat
• •Valid driver's license and current automobile insurance
• •The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job
• •The employee must have the ability to lift, pull, push, and manipulate equipment and patients, which requires strength and gross motor and fine motor coordination
• •The employee must be able to administer prescribed treatments
• •The position requires sitting and/or standing for long periods of time
• •The position requires the ability to operate a computer
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Responsibilities

• •A Clinical Research Assistant, or CRA, is responsible for organizing and overseeing clinical studies or trials to contribute to advances in the medical community
• •Their duties include contacting individuals to participate in trials, reviewing medical histories of each participant before approval and writing reports to determine the overall success of a new drug, procedure or medical device
• •CRAs typically work for research facilities, clinical agencies and pharmaceutical companies to coordinate clinical trials
• •They work closely with other clinical research professionals to test new drugs, procedures and biotechnology that could benefit modern medical practices and patient ailments
• •Their job is to analyze the potential risks of the trial and consult with other professionals to determine what safety protocols to use
• •They may also be responsible for establishing and maintaining relationships with data management facilities to provide study or trial results
• •Supervise study sites and activities to ensure adherence to appropriate industry protocols and terms of the study
• •Collect and authenticate data collection forms otherwise known as case report forms
• •Screen potential study participants through medical record reviews, interviews and follow-ups with healthcare providers
• •Ability to escalate potential safety issues to the appropriate clinical research personnel
• •Maintain specific records of research activity to include regulatory forms, drug dispensation records, case reports and consent forms
• •Ensure proper transmission of clinical case data to the data management centers, review case reports questions and problems and clarify or obtain alterations to data as appropriate
• •Oversee research, technical and administrative staff, to include training, hiring, goal setting and distribution of workload
• •Provides administrative support to ensure efficient operation of office
• •Assists with patient care and collection of medical history, medications and other data necessary for conducting clinical trials
• •Data entry into medical records
• •Exhibits polite and professional communication via phone, e-mail, and mail
• •Supports team by performing tasks related to organization and strong communication
• •Provides information by answering questions and requests
• •Maintains supplies inventory by checking stock to determine inventory level, anticipating needed supplies, and placing and expediting orders for supplies
• •Contributes to team effort by accomplishing related results as needed
• •Performs various medical procedures including (not limited to): patient vitals, phlebotomy, run labs, EKG, etc
• •Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
• •Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects
• •Understand basic elements of regulatory documentation
• •Maintain confidentiality of patient protected health information, sponsor confidential information and CARE confidential information
• •Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed
• •Prepare source document charts, copy and/or file medical records and study related documents as required
• •Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems
• •Other duties as assigned
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