Senior Clinical Research Monitor

Integrated 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 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 (North East), Region 4 or 5 (Midwest) and Region 6 (West Coast).

POSITION DESCRIPTION:

· The Senior Clinical Research Monitor is responsible for the ov
ersight 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.

• 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…