Clinical Research Assistant - Phlebotomy & Data Entry

Velocity-Clinical-Research,-Inc.; Lincoln (NE); On-site; USD 36,000 - 60,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid time off

Company holidays

401(k) with company match

Annual incentive program

Job summary

Velocity Clinical Research is seeking a Clinical Research Assistant to support the Clinical Operations Team in collecting, documenting, and maintaining clinical data, including phlebotomy and data entry, with emphasis on accurate source documentation.

The role involves coordinating with sponsors, CROs, and patients, maintaining confidentiality, and assisting in recruitment tasks while adhering to GCP and Velocity SOPs.

Qualifications

• High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry.

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

MS Office

Communication skills

Team player

English proficiency

Multitasking

Flexibility

Computers

Office equipment

Education

High school graduate or technical degree

Tools

Computers

Microsoft Office

Fax machine

Copier

Multi-line telephone

Job description

Velocity Clinical Research is seeking a Clinical Research Assistant to support the Clinical Operations Team in collecting, documenting, and maintaining clinical data, including phlebotomy and data entry, with emphasis on accurate source documentation.

The role involves coordinating with sponsors, CROs, and patients, maintaining confidentiality, and assisting in recruitment tasks while adhering to GCP and Velocity SOPs.