Job Title: Senior Clinical Research Monitor
Location: Mounds View, MN
Duration: 24+ (possibility of extension)
MANDAOTORY 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 policies
• Communicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-up
• Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan
• Identify site needs, provide solutions to facilitate the clinical trial process
• Act as a primary point of contact for study sites as requested
• Provide input into the development and improvement of investigator and site management systems (e.g., CTMS)
• Assist in initial and ongoing site personnel training as required
• Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures
• Propose 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 product
• Possess understanding of regulatory requirements
• Mentor and/or train junior personnel
• Assist sites/study teams with audit preparation
• Adhere to all applicable Healthcare policies and procedures
In addition, the Senior Clinical Research Monitor may:
• Attend Investigator and/or Coordinator meetings
• Prepare meeting presentations and/or deliver training during meetings (Investigator/Coordinator meetings, study/monitoring team meetings, etc.)
• Provide input into final study site selection
• Be involved in site management activities
• Be assigned lead monitor responsibilities which include but are not limited to:
o Providing input on study protocol, CRFs and other study documents
o Authoring Monitoring Plans, monitoring section of Data Management Plans, and source document worksheets
o Assisting in the creation of corrective and preventive action plans and trending reports
o Managing site assignments in collaboration with manager
o Facilitating communication and information flow between assigned project teams and assigned monitors on project
o Ensuring monitors are trained, current with project requirements and understand study milestones
o Overseeing action item tracking and resolution status
o Performing co-monitoring visits as needed
o Ensuring Monitoring Plan requirements are being met and escalates risks
o Attending Core/Study team meetings
BASIC QUALIFICATIONS:
Education Required:
·Bachelor's Degree in life sciences, nursing or other health related disciplines
Years 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 experience
DESIRED/PREFERRED QUALIFICATIONS
• Cardiovascular experience
• Experience monitor Device Trials
• Excellent interpersonal skills
• Experience working in a team/matrix environment requiring strong working relationships
• Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
• Ability to work in a fast paced environment
• Competencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfaction
• Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands.
• High attention to detail and accuracy
• Experience working independently in a regional area with remote or minimal supervision
• Strong leadership skills
• Excellent problem solving skills
• Experience 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 industry
• Class III medical device and/or phase II, III and IV pharmaceutical experience
• Experience to demonstrate understanding of technical, scientific and medical information
• Experience with Regulatory and Quality Assurance audits
• Experience of conducting clinical research activities in a regulated environment
• Proficient knowledge of medical terminology
• Regulations/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