Clinical Research Assistant
CARE · Idaho Falls, Idaho, United States · On-site
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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.
Responsibilities
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…