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Clinical Research Assistant - EMT/LPN/MA/CPhT

Company: Wake Research
Location: Fayetteville
Posted on: August 7, 2022

Job Description:

M3 Wake Research Inc. is one of the largest independent clinical research site services companies in North America. Wake Research has 21 owned and managed research sites across 8 states in the US and continues to grow. Due to continued growth and expansion, we are seeking a Clinical Research Assistant for our Fayetteville, NC location.The Clinical Research Assistant (RA) is a research professional working with and under the direction of the clinical research site management, Principal Investigator (PI), and clinical research staff.While the PI is primarily responsible for the overall conduct and management of the clinical trial, the Research Assistant supports the clinical research staff with daily clinical trial activities and plays an important role in the conduct of the study.By performing these duties, the research assistant works with the PI, site management and clinical research staff to support all aspects related to the conduct of clinical trials.The primary concern of all Wake Research personnel is the protection of study subjects.RequirementsGeneral / AdministrativeCompletes all site trainingrequirements including but not limited to: GCP training, IATA training,OSHA training, site SOP review, individual department training.Completes training on andshows competency with clinical skills as delegated (phlebotomy, vitalsigns, ECG, PFT's etc).Cooperates with site managementand monitoring efforts to ensure protocol adherence.Reports instances of noncompliance tothe lead study coordinator or site management. Assists with coordinatingand facilitating monitoring visits. Study Preparation Reviews and comprehends assignedprotocol.Attends research meetings forassigned studies as required. Prepares study materials forassigned studies. These study materials may include but are notlimited to:source documentcreation, adverse event and concomitant medication logs, drug/deviceaccountability logs, subject visit spreadsheets, chart preparation.Assists with organizing studyfiles, including but not limited to, regulatory binders and othermaterials. Attend site initiation visit(SIV) and attends protocol training/team meetings prior to start ofscreening.Communicates with lead studycoordinator to help ensure there are no delays in the start-up of assignedstudy. (i.e. all required training has been completed by appropriatestaff,all study supplies have beenreceived, IRB approval has been obtained, etc.). Conduct of ResearchAssist with recruitmentstrategies and collaborate with recruitment department to ensure suitablesubjects meet study criteria.Performs study relatedprocedures according to study protocol as trained (i.e. Vital signs, ECG,phlebotomy, pulmonary function testing, urine pregnancy and drug testing,processing blood, or any other procedures required per protocol or orderedby study investigator). Collects data on sourcedocumentation as required by the protocol. Assists with timelycompletion of Case Report Forms.Helps to Maintain regulatoryfiles throughout the conduct of the entire trial. Reviews study supplyinventory to ensure site has adequate inventory of all study supplies. Whenhandling investigational drugs/devices, follows the protocol forInvestigational Drug/Device Accountability.Maintains effective andongoing communication with Lead study coordinator, site management and PIduring the course of the study.Works with lead studycoordinator to assist with resolving any issues that may arise during theconduct of the study or during a monitor visit.Involve management with any issues whereassistance may be required. Project CloseoutAssist lead studycoordinator with close-out visit activities (i.e. drug reconciliation,drug return, IRB close-out report, regulatory document filing) Benefits Competitive salary Advancement and career opportunities 401(k), 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance

Keywords: Wake Research, Fayetteville , Clinical Research Assistant - EMT/LPN/MA/CPhT, Healthcare , Fayetteville, North Carolina

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