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Company | Velocity Clinical Research, Inc. |
Address | Savannah, GA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-09-18 |
Posted at | 8 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.
- 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
- 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 basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial
- Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity’s SOPs
- 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
- With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations
- Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed
- 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
- Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial
- Prepare source document charts, copy and/or file medical records and study related documents as required.
- Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
- Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems.
- Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information
- Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects
- Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team
- Other duties as assigned
- High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry
- Intramuscular dose administration and preparation if applicable and required by state law
- Phlebotomy if applicable and required by state law
- Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
- Demonstrated knowledge of medical terminology
- Demonstrated ability to work as a team player
- Demonstrated ability to use the following technology Computers, Microsoft Office software, fax, copier, and multi-line telephone.
- Understanding of verbal, written, and organizational skills
- Demonstrated ability to multi-task
- Demonstrated ability to follow written guidelines
- Demonstrated ability to read, write, and speak English
- Limited to lifting up to 30 pounds
- Sit or stand for long periods of time
- Limited walking required
- Communicate in person and by a telephone
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