Clinical Research Assistant

Velocity Clinical Porter County, IN, IN
clinical research research assistant research data clinical research operations team protocol subjects phlebotomy laboratory director
December 9, 2022
Velocity Clinical
Porter County, IN, IN
FULL_TIME


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


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