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SMA I

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About the role

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"At ICON, it's our People that set us Apart"
 
 
Do you have experience managing, implementing and monitoring clinical studies, with support, in a team setting according to ICON SOPs, SSPs and all applicable rules and regulations?
 
Site Management Associate I role within ICON: 
 
ICON has a strong reputation in our approaches to clinical development.   We apply scientific and operational excellence across all phases of clinical trial outsourcing services for our clients.   We work with top pharmaceutical organizations on emerging therapeutic areas which include but are not limited to Oncology, Vaccines, CNS, Cardiovascular and Pain.  We are presently in over 40 countries with over 80 offices worldwide and over 10K employees globally. 
 
The SMA I is responsible for managing, implementing and monitoring clinical studies, with support, in a team setting according to ICON SOPs, SSPs and all applicable rules and regulations.  The responsibilities of this position include, but are not limited to: identifying, training/initiating and closing out study sites; conducting remote site monitoring visits and/or targeted on-site visits as needed, conducting remote site management activities, managing study sites and the required protocols, amendments and/or deviations, assuring that data is reported accurately and timelines are maintained.
 
  • Ability to work on study teams that are often virtual, multi-cultural, and multi-disciplinary
  • Serves as the primary contact for sites and investigators participating in studies
  • Acts as a resource for internal study teams and other ICON departments
  • Maintains, reviews, and ensures adequacy of information and data contained in site management reports, tracking systems (CTMS or others) and other site management documents
  • Conducts and completes remote site management activities, with support as needed, according to applicable SOPs and the Site Management Plan
  • Participates in QA audits as needed
  • Regularly attends and contributes to project specific and departmental meetings
  • Ability and willingness to travel as needed (drive and fly) – approximately 25% of the time
  • Reviews drug storage and drug accountability procedures (as applicable), in accordance with applicable SOPs
  • Maintains and archives study documentation and correspondence, as needed
  • Assists with site contracting process, as needed
  • Assists with timely preparation and submission of regulatory documents for IRB/IEC submissions according to local requirements, with support, as needed
  • With support, demonstrates the ability to manage site assignments and workload
  • Maintains Sponsor and patient confidentiality
  • Actively participates in regular meetings with Project Managers or delegate, and/or RS Lead
  • Assists in development of site and patient enrolment strategies with project team; works to motivate sites to meet enrolment timelines
  • Developing knowledge of and compliance with local regulatory requirements
  • Compliant and current with departmental and corporate policies and procedures
 
Benefits of working at ICON:
In addition to partnering with the top pharmaceutical and biotech companies in the world we offer a strong benefits package that includes a comprehensive health plan, retirement plans, competitive pay, bonus plans, vacation, and other incentives.  
 
To succeed you will need:
We are seeking candidates with a bachelor’s degree, or local equivalent, in medicine, science or related discipline. You must have a minimum of one year of relevant experience is preferred. Experience in a health care and/or research environment.  Prior relevant monitoring experience preferred.
 
To be successful you will be expected to review and evaluate clinical data, be computer literate and have excellent oral and written (English) communication skills. 
 
We invite you to review our opportunities at www.iconplc.com/careers.
 
What’s Next?
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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