Job Description
Job Title:
Research Assistant
Position Description:
Assist the Clinical Operations Team in a multifunctional 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.
Position Reports To:
Site Manager/Site Director
Position Qualification Requirements:
Education:
* 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 Abilites:
* 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
Position 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
Title
Print Name
Signature
Date
Research Assistant, Site Operations
Site Director or Head of Operations
Author: Christine Gorgas, Senior Director Operations
Approver: Melissa Holbrook, VP Operations
Version: 26May2021
Recommended Skills
- Administration
- Clinical Assessments
- Clinical Research
- Clinical Research Coordination
- Clinical Trials
- Clinical Works