Clinical Research Assistant

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high-quality data, and fully integrated research sites. We align our values and behaviors to give 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.

About the role

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.

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 the scope of the protocol and local law and regulations.
• With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc.) within the 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 the 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.
• 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.
• Escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team.
• Clean, organize, and disinfect 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.

Requirements

• High School Graduate and/or technical degree with a minimum of 1 year of relevant experience in the life sciences industry.
• Phlebotomy certification if applicable and required by state law.
• Intramuscular dose administration and preparation certification if applicable and required by state law.

Skills

• Demonstrated knowledge of medical terminology.
• Demonstrated ability to use computers, Microsoft Office software, fax, copier, and multi-line telephone.
• Strong 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 the daily schedule may change rapidly.

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.

Benefits

• Medical, dental, and vision insurance.
• Paid time off and company holidays.
• 401(k) retirement plan with company-match.
• Annual incentive program.