Senior Clinical Research Associate

Senior Clinical Research MonitorIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job Title: Senior Clinical Research MonitorLocation: Mounds View, MN Duration: 24+ (possibility of extension) Mandatory Required 1) Device experience 2) Cardiovascular experience There is a total of 3 openings and they need 1 candidate in each region below: Region 1 (NorthEast), Region 4 or 5 (Midwest) and Region 6 (West Coast).Position Description:· The Senior Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with applicable regulatory standards, IRB/EC policies and procedures and Business requirements.· This position works under minimal supervision, working closely with study teams, site personnel, and Healthcare field personnel and monitoring supervisor for resolution of site issues.· The Senior Clinical Research Monitor may play a leadership role in managing monitoring activities.Position Responsibilities:Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Healthcare standards, guidelines and policiesCommunicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-upPrepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring PlanIdentify site needs, provide solutions to facilitate the clinical trial processAct as a primary point of contact for study sites as requestedProvide input into the development and improvement of investigator and site management systems (e.g., CTMS)Assist in initial and ongoing site personnel training as requiredIdentification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating ProceduresPropose solutions and collaborate with monitoring management and study team personnel towards securing Investigator compliance.Understand the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.)Possess a working knowledge of disease state and investigational productPossess understanding of regulatory requirementsMentor and/or train junior personnelAssist sites/study teams with audit preparationAdhere to all applicable Healthcare policies and proceduresIn addition, the Senior Clinical Research Monitor may:Attend Investigator and/or Coordinator meetingsPrepare meeting presentations and/or deliver training during meetings (Investigator/Coordinator meetings, study/monitoring team meetings, etc.)Provide input into final study site selectionBe involved in site management activitiesBe assigned lead monitor responsibilities which include but are not limited to:Providing input on study protocol, CRFs and other study documentsAuthoring Monitoring Plans, monitoring section of Data Management Plans, and source document worksheetsAssisting in the creation of corrective and preventive action plans and trending reportsManaging site assignments in collaboration with managerFacilitating communication and information flow between assigned project teams and assigned monitors on projectEnsuring monitors are trained, current with project requirements and understand study milestonesOverseeing action item tracking and resolution statusPerforming co-monitoring visits as neededEnsuring Monitoring Plan requirements are being met and escalates risksAttending Core/Study team meetingsBasic Qualifications:Education Required: Bachelor's Degree in life sciences, nursing or other health related disciplinesYears Of Experience: Four (4) years clinical research experience with at least two (2) years of clinical monitoring experience or Master's degree with 2 years clinical research experienceDesired/Preferred Qualifications:Cardiovascular experienceExperience monitor Device TrialsExcellent interpersonal skillsExperience working in a team/matrix environment requiring strong working relationshipsAbility to handle and prioritize multiple therapeutic areas and projects simultaneouslyAbility to work in a fast paced environmentCompetencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfactionDemonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands.High attention to detail and accuracyExperience working independently in a regional area with remote or minimal supervisionStrong leadership skillsExcellent problem solving skillsExperience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)Applied understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.)Business knowledge or experience with the medical / healthcare industryClass III medical device and/or phase II, III and IV pharmaceutical experienceExperience to demonstrate understanding of technical, scientific and medical informationExperience with Regulatory and Quality Assurance auditsExperience of conducting clinical research activities in a regulated environmentProficient knowledge of medical terminologyRegulations/standards training (FDA, ISO, GCP and other country specific training, such as for Canada, Asia, Latin American, etc. as applicable)Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training)Physical Job Requirements:The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Ability to travel up to 80% Travel with colleagues and manager as requested May require international travel