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Array BioPharma

Sr. CRA
Job#: 13001
Posted: 02/22/2013
Location: Morrisville, NC or Boulder, CO
Category: Clinical
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Responsibilities

Summary:

These positions may reside in Morrisville, NC or Boulder, CO.  They will be responsible for supporting clinical studies to meet required quality standards, and to make sure the studies are on schedule and on budget. Requires up to 60% travel.

 Responsibilities:

  • Perform all site management and monitoring activities in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, trial protocols, and Array Standard Operating Procedures (SOPs), monitoring plans. and business processes
  • Conduct site qualification, initiation, interim monitoring, co-monitoring, and study closeout visits
  • Ensure regulatory and protocol compliance of investigators and sites
  • Ensure quality of data submitted from study sites and assure timely submission of data, including proactive cooperation with data management to identify and resolve data discrepancies
  • Monitor safety and protection of study subjects, including appropriate reporting and follow-up for all safety events by site personnel
  • Review investigator study files and reconcile versus trial master files
  • Ensure investigational product accountability accurately maintained
  • Ensure that  study site personnel have been trained on the protocol, CRFs, study manuals and tools, and applicable regulatory requirements as is appropriate for their level of delegated responsibility
  • Ensure regulatory inspection readiness at assigned clinical sites
  • Report monitoring activities and study site conduct accurately and completely
  • Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner
  • Assist in managing clinical studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
  • Support feasibility and site selection processes for assigned studies
  • Assist in the training and supervision of field monitors, and Contract Research Organizations
  • Establish effective relationships with clinical investigators and staff, CROs, and vendors and influence them to meet study objectives
  • Proactively identify and resolve site management issues
  • Assist with the design and development of clinical trial protocols, case report forms, informed consent forms, and study documentation
  • Ability to travel approximately 60% of the time (primarily domestic sites with potential for international travel) 
Skills and Requirements
  • Associate degree required, plus 3 years’ experience in clinical trials with 2 of those years in a monitoring role (for CRA)
  • Associate degree required (BS/BA desired) plus 5 years’ experience in clinical trials with 3 of those years in a monitoring role (for Sr. CRA)
  • Ability to travel up to 60% including international travel
  • Demonstrated experience managing multiple tasks with competing deadlines under limited direction while generating quality deliverables
  • Strong site management and monitoring skills
  • Good knowledge of the clinical development process, understanding concepts of Phase I-IV
  • Good knowledge and understanding of clinical trial management and reporting
  • Good knowledge of the data management processes and principles
  • Experience in document maintenance and management
  • In depth knowledge of ICH/GCP guidelines, and basic regulatory requirements
  •  Understanding of therapeutic area/study rationale

Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer. We offer an excellent compensation package including a competitive salary, company ownership and comprehensive benefits.

Array is an equal opportunity employer and drug free workplace.. .  

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