Job Description

Position Overview Clinical Research Assistant at Velocity Clinical Research, Inc. Benefits Medical, dental, and vision insurance; paid time off; company holidays; 401(k) retirement plan with company match; annual incentive program. Summary The Clinical Research Assistant supports the Clinical Operations Team in data collection, documentation, and maintenance of clinical data, including phlebotomy, laboratory, data entry, and administrative responsibilities. Responsibilities Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity’s SOPs Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial Enter source data into the sponsor's and/or vendor’s data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team 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 Education & Experience High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry Required Licenses/Certifications Phlebotomy if applicable and required by state law Intramuscular dose administration and preparation if applicable and required by state law Required Skills Demonstrated knowledge of medical terminology Demonstrated ability to use computers, Microsoft Office software, fax, copier, and multi-line telephone Understanding of verbal, written, and organizational skills Demonstrated ability to work as a team player Demonstrated ability to read, write, and speak English Demonstrated ability to multi-task Demonstrated ability to follow written guidelines Demonstrated ability to be flexible/adapt as daily schedule may change rapidly Required Physical Abilities Sit or stand for long periods of time Communicate in person and by telephone Limited walking required Limited to lifting up to 30 pounds NOTE: The above job description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management. #J-18808-Ljbffr Velocity Clinical Research, Inc.

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