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Clinical Research Assistant Jobs
Company | Velocity Clinical Research, Inc. |
Address | Omaha, NE, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-06-15 |
Posted at | 11 months ago |
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.
- The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities.
- 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
- Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team
- With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations
- Prepare source document charts, copy and/or file medical records and study related documents as required.
- Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed
- 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
- Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
- 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
- Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity’s SOPs
- Other duties as assigned
- Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial
- Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects
- Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information
- Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
- 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
- Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems.
- Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial
- High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry
- Phlebotomy if applicable and required by state law
- Intramuscular dose administration and preparation if applicable and required by state law
- Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
- Demonstrated ability to use the following technology Computers, Microsoft Office software, fax, copier, and multi-line telephone.
- Demonstrated ability to work as a team player
- Demonstrated ability to read, write, and speak English
- Demonstrated ability to follow written guidelines
- Demonstrated knowledge of medical terminology
- Demonstrated ability to multi-task
- Understanding of verbal, written, and organizational skills
- Limited walking required
- Limited to lifting up to 30 pounds
- Communicate in person and by a telephone
- Sit or stand for long periods of time
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