Clinical Research Assistant

Velocity Clinical Research, Inc.; Cleveland (OH); On-site; USD 42,000 - 56,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Paid time off and holidays

401(k) with company match

Annual incentive program

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 tasks, under GCP guidelines.

The role involves coordinating with sponsors, CROs, and study subjects; performing venipuncture under protocol, maintaining inventory, and ensuring confidentiality. Strong organizational skills, teamwork, and English proficiency are essential.

Qualifications

• High School graduate with at least 1 year of relevant life sciences experience.
• Phlebotomy and intramuscular administration certifications may be state dependent.
• Strong knowledge of medical terminology and basic lab practices.

Responsibilities

• Assist in conduct of clinical trials per protocol and GCP.
• Perform venipuncture and capillary puncture within scope.
• With supervision, perform clinical assessments (vital signs, phlebotomy, ECG).
• Process, package and ship laboratory specimens per protocol and IATA regulations.
• Track, order and maintain inventory of laboratory supplies.
• Enter source data into sponsor/vendor data portals and resolve queries.
• Communicate with coworkers, leadership, sponsors, CROs and vendors.
• Understand informed consent and maintain confidentiality.
• Support patient recruitment activities including prescreening.
• Maintain confidentiality of patient information and velocity confidential data.
• Front office duties: answer phones, schedule subjects, reminders.

Skills

Medical terminology

Microsoft Office

English proficiency

Team player

Multi-tasking

Attention to guidelines

Adaptability

Education

High School Diploma with 1 year life sciences experience

Tools

Computers

Fax

Copier

Multi-line phone system

Job description

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.

• medical, dental and vision insurance
• paid time off and company holidays
• 401(k) retirement plan with company-match
• 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 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

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.