Versiti: Coordinator Clinical Research

Company: Versiti
Location: Milwaukee
Posted on: November 21, 2020

Job Description:

Under the direction of the Principal Investigators (PIs) and CTRO Supervisor, is responsible for coordinating research trials from initiation to completion in compliance with regulations and requirements. Assists in the management of trial budgets and implements and oversees systems to manage the conduct of the clinical trials and the flow of information among stakeholders.Subject Interaction:Obtains consent and enrolls study subjectsCommunicates with study subjects, ensuring they receive applicable information. May include training and education regarding the studyServes as a liaison between study subjects and Principal Investigator/research team to provide proactive communicationMay collect samples from subjects as applicable/assignedStakeholder Interaction:Serves as a liaison with stakeholders including members of the research team, IRB (Institutional Review Board), study sponsors, hospitals/hospital staff, BCW staff, national data coordinating centers, and granting agencies. May include training and education regarding the study Ensures receipt of applicable study data, reports, contracts, and informationAdministrative Responsibilities:Coordinates the conduct of the clinical research project and protocols from initiation to completion in compliance with regulations and requirementsDesigns, oversees, evaluates, and improves systems and processes to manage the conduct of the clinical trial and the flow of information among stakeholders Prepares a variety of written materials that support the research study such as IRB documents, contracts/subcontracts, grants, manuscripts, educational and promotional materials, etc.Coordinates the collection and required reporting of applicable data to ensure smooth and accurate flow of information and when required, assists with data analysisPrepares and manages clinical trial budgets, ensuring appropriate expenditures and resource utilization, while working with Versiti grants administration regarding local and national budget issues Designs, maintains and modifies databases, data entry/retrieval and record keeping systemsSupervises sample handling, storage, and shipment Assists with study audits and performs the necessary steps to resolve any queries Assists with and develops quality assurance procedures; evaluates study forms for completeness, accuracy and compliance with protocolsConfirms and Documents all study activities on the appropriate financial documents. May complete study specific invoicing. Participates in study budget design and review. General Responsibilities:Maintains confidentiality of all subject-related records including written and verbal communications Assists the Principal Investigator in day-to-day operations of the projectsCoordinates on-site and off-site meetings for project planning purposes and educational events as assignedParticipates in process improvement activitiesParticipates in meetings, professional activities, etc. to keep current in skills and knowledgeMay serve as the Clinical Trial Management Software (CTMS) AdministratorMay provide coverage for others and/or may instruct and direct the work of othersEducationHigh School Diploma or equivalent requiredBachelor's degree in science or another related field or equivalent work experience requiredExperienceTwo years of experience in a health care or research setting requiredFive years of healthcare/research experience preferredTwo years of Clinical Research Experience preferredExperience with related clinical research preferredACRP CCRC or SOCRA CCRP certification preferredPhlebotomy experience preferredSkills and KnowledgeStrong customer service and interpersonal skillsAbility to be an effective liaison between study subjects and sponsors, investigators, health care workers, and collaborating professionalsProficient verbal and written communication skills including the ability to write, interpret and explain research studies and proceduresStrong ability to implement and manage projects that include planning, organization, prioritization, problem solving and performance of project tasks to ensure project completion within designated timeframesVery strong attention to detail and ability to evaluate and ensure accuracy of data related to laboratory results, subject health history, and data collection and reportingStrong proficiency with database functionalityAbility to evaluate and extract data from medical records with ability to spot errors and trends and address promptlyA leader in flexibility and dedication for handling a demanding, irregular schedule under pressure to meet deadlinesStrong knowledge of regulations associated with human subject research preferredAbility to work in a highly independent mannerValid WI driver's license and access to a vehicleConsistently strives to enhance existing services and influence resulting action plansBuilds teamwork, works collaboratively with team members and colleagues Has substantial understand of the job and applies knowledge and skills to complete a wide range of tasks Typically encounters differing situations requiring the identification of issues, the application of judgement, and the selection of solutions within the area of expertise and acquired knowledge. Requires objective review of difficult work problems, obtaining cooperation or approval. Requires resourcefulnessHas substantial understanding of the technical scope of the job and applies knowledge and skills to complete a wide range of tasksTools and TechnologyPersonal Computer (desk top, lap top, tablet)General office equipment (computer, printer, fax, copy machine)Microsoft Suite (Word, Excel, PowerPoint)EPIC medical record systemElectronic Data Capture systems such as Velos, Redcap, Medidata, Inform, etc.PHYSICAL REQUIREMENTS & WORKING CONDITIONSIndicate the amount of time by checking the appropriate boxes below.Include the major physical activities in the job description and reference minor areas by saying " Occasionally may require," etc.: Mostly sedentary position with some standing and walkingAmount of Time None1/3 to 2/3> 2/3 StandX WalkX SitX Use hands to finger, handle or touchX Reach above shouldersX Climb or balanceX Stoop, kneel, crouch, or crawlX Talk or hearX Taste or smellX Does this job require that weight be lifted, or force be exerted? If so, how much and how often? Check the appropriate boxes below.Amount of Time None1/3 to 2/3> 2/3 Up to10 poundsX Up to 25 poundsX Up to 50 poundsX Up to 100 poundsX More than 100 poundsX Describe the specific job duties that require the physical demands selected above (" Required to lift boxes up to 50 pounds and carry them 50 feet." ). Lift up to 10 lbs. of paperwork and/or laptop computer.Does this job have any special vision requirements? Check all that apply.--' Close vision (clear vision at 20 inches or less).--- Distance vision (clear vision at 20 feet or more).--- Color vision (ability to identify and distinguish colors).--- Peripheral vision (ability to observe an area that can be seen up and down or to the left and right while eyes are fixed on given point).--- Depth perception (three-dimensional vision, ability to judge distances and spatial relationships).--' Ability to adjust focus (ability to adjust the eye to bring an object into sharp focus).--- No special vision requirements.How much noise is typical for the work environment of this job? Check all that apply.--- Very Quiet (examples: forest trail, isolation booth for hearing test).--- Quiet (examples: library, private office).--' Moderate (example: normal shop conditions).--- Loud (example: higher than normal shop conditions).--- Very Loud (example: loud machinery).Is there anything on this list that applies to the position? If so, how much exposure to the following environmental conditions does this job require? Indicate the amount of time by checking the appropriate boxes below.Amount of Time None1/3 to 2/3> 2/3 Exposure to blood or other bodily fluidsX Wet, humid conditions (non-weather)X Work near moving mechanical partsX Work in high, precarious placesX Fumes or airborne particlesX Toxic or caustic chemicalsX Outdoor weather conditionsX Extreme cold (non-weather)X Risk of electrical shockX Work with explosivesX Risk of radiationX VibrationX Work/job-related travelXList all protective clothing or protective equipment required to perform the job. PPE is provided (gloves, lab coats, safety glasses or goggles)Closed toed shoes are required in all lab and patient care areasThis job description reflects the current assignment of essential functions and is not meant to be all-inclusive or in any way construed as an employment contract. Duties and responsibilities may be assigned or reassigned to this position at any time and may be modified to reasonably accommodate an individual with a disability or for other reasons solely at management's discretion. All position descriptions will be reviewed and updated at least once per year when the incumbent is reviewed or as attrition occursEqual Opportunity Employer. This company will provide equal opportunity to all individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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