Clinical Research Assistant: Hands-On Trials & Data

Velocity Clinical Research, Inc.; Glendale (OH); On-site; USD 37,000 - 54,000; Full time

Job summary

Velocity Clinical Research, Inc. is seeking a Clinical Research Assistant to support the Clinical Operations Team in data collection, documentation and maintenance of clinical data, including phlebotomy and lab responsibilities.

You will perform duties under supervision, ensure adherence to GCP and ICH guidelines, handle front office tasks and participate in patient recruitment while maintaining patient confidentiality and regulatory documentation.

Qualifications

• High School Diploma or technical degree with at least 1 year in life sciences.
• Phlebotomy certification if applicable and required by state law.
• Intramuscular dose administration and preparation if applicable and required by state law.
• Knowledge of medical terminology.
• Ability to use MS Office, computers, and multi-line telephone systems.

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 elevate 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

Skills

Medical terminology

Computer literacy

Microsoft Office

Verbal communication

Written communication

Organizational skills

Teamwork

English proficiency

Education

High School Diploma or Technical Degree

Job description

Velocity Clinical Research, Inc. is seeking a Clinical Research Assistant to support the Clinical Operations Team in data collection, documentation and maintenance of clinical data, including phlebotomy and lab responsibilities.

You will perform duties under supervision, ensure adherence to GCP and ICH guidelines, handle front office tasks and participate in patient recruitment while maintaining patient confidentiality and regulatory documentation.