Integrated Resources Inc.
Sr. Clinical Research Specialist
Integrated Resources Inc., Minneapolis, Minnesota, United States, 55400
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 Description
Job Title:
Sr. Clinical Research SpecialistLocation:
Minneapolis, MNDuration:
24+ Months (Possibility of extension)Local candidate:
Minneapolis, MN needed
Position Description:
The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Healthcare requirements.
Position Responsibilities:Prepare and revise study materials and/or trainingConduct training of site and/or Healthcare staffAssist in site initiation activities (e.g. study start-up documentation preparation)Set-up and maintain accurate progress and study status tracking logsAssist in the preparation of reports, regulatory submissions, publications and presentationsAssist in the preparation of budgets and project plansIdentify and mitigate quality risk and/or issues associated with assigned studies/activitiesMay arrange conference calls, staff meetings, and training events.Assist in the preparation and review of dataOversee follow-up and resolution of sites issuesOversee activities performed by extended team members including work direction (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelinesAble to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasksContribute to process improvement initiatives and participate in training to enhance knowledgeBasic Qualifications:4+ years’ experience in clinical research (Master’s degree will substitute for 1 year experience)Desired/Preferred Qualifications:Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studiesProficient knowledge of medical terminologyComputer skill competency (MS Office products, spreadsheets, power points, etc.)Ability to work well within teams, build relationshipsGood prioritization and organizational skills, able to manage multiple tasksExcellent oral and written communicationPositive outlookStrong communication skills (efficient, effective, transparent)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 10-20%
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Job Description
Job Title:
Sr. Clinical Research SpecialistLocation:
Minneapolis, MNDuration:
24+ Months (Possibility of extension)Local candidate:
Minneapolis, MN needed
Position Description:
The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Healthcare requirements.
Position Responsibilities:Prepare and revise study materials and/or trainingConduct training of site and/or Healthcare staffAssist in site initiation activities (e.g. study start-up documentation preparation)Set-up and maintain accurate progress and study status tracking logsAssist in the preparation of reports, regulatory submissions, publications and presentationsAssist in the preparation of budgets and project plansIdentify and mitigate quality risk and/or issues associated with assigned studies/activitiesMay arrange conference calls, staff meetings, and training events.Assist in the preparation and review of dataOversee follow-up and resolution of sites issuesOversee activities performed by extended team members including work direction (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelinesAble to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasksContribute to process improvement initiatives and participate in training to enhance knowledgeBasic Qualifications:4+ years’ experience in clinical research (Master’s degree will substitute for 1 year experience)Desired/Preferred Qualifications:Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studiesProficient knowledge of medical terminologyComputer skill competency (MS Office products, spreadsheets, power points, etc.)Ability to work well within teams, build relationshipsGood prioritization and organizational skills, able to manage multiple tasksExcellent oral and written communicationPositive outlookStrong communication skills (efficient, effective, transparent)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 10-20%
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