Clinical Research Assistant

Overview
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.
As an employee of Velocity, you are the most integral part of our mission.
For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance.
Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.
Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.
Summary:
The Clinical Research Assistant assists the Clinical Operations Team in a multi-functionalcapacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities.
Responsibilities
Duties/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
Qualifications
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 the following technology: 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 a 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.
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