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Senior CRA/Clin Ops Leader

New Jersey All, NJ

Post Date: 05/08/2018 Job ID: JN -052018-21531 Job Type: Clinical
  • Reports to Director of Clinical Operations, and may serve as Clin Ops Leader/Project Manager for individual clinical trials or manage clinical sites in one or more clinical trials
  • Provides input into the development of protocols, ICFs and amendments
  • Develops study conduct plans and templates where applicable (e.g. Monitoring Plan, Source Document Verification Plan, CRF Completion Guidelines, etc.)
  • Provides oversight of CRO monitoring activities including review of metrics representing quality and deliverables (e.g. monitoring visits, data collection activities, data query rates, etc.), as well as, direct oversight of clinical monitor activities (e.g. trip report review, co-monitoring)
  • May co-monitor with contract/CRO monitoring staff to evaluate site/monitor adherence to protocols, review study progress, evaluate performance, provide monitoring support when needed, etc.
  • Participates in clinical vendor selection process when appropriate
  • Assists with the planning and execution of investigator/study coordinator/monitor meetings
  • Develops protocol specific CRFs and any other tools used to collect data
  • Responsible for ensuring authorized sites to always have supplies on hand during the treatment phase of the study and coordinating with supply chain colleagues on IP shipments and inventory tracking and management
  • Participates in the selection and oversight of contract Clinical Research Associates (CRAs); reviews reports and ensures timely resolution of issues
  • Reviews CRO invoices and verifies that invoiced items are consistent with activities and charges are appropriate before approval
  • Ensures SAEs are processed and closed in a timely manner and that sites have followed their site-specific reporting requirements
  • Leads CRA team meetings, answers CRA study-related questions
  • Participates in the clinical review of study data; creates and/or resolves data queries as needed
  • Attends clinical team meetings and provides updates as needed
  • Effectively communicates to internal stakeholders and external study team members, as appropriate, to ensure adequate distribution of information and coordination of activities
  • Ensures the team tracks and manages deliverables
Requirements
  • Ideally a bachelor's degree; nursing background is a plus
  • Approximately 5-10+ years in the clinical research industry
  • 5 years of demonstrated proficiency in all aspects of site monitoring
  • Oncology (Phase I) monitoring experience; experiences in later phases of clinical trial a plus but not a requirement
  • Demonstrated independence in performing site monitoring (e.g. site selection, site initiation, interim monitoring and closeout visits) and site management activities
  • Experience with electronic data capture
  • Able to lead, motivate and coordinate teams
  • Ability to coach/mentor team members as appropriate
  • Experience liaising with and coordinating cross-functional project teams
  • Able to delegate, effectively prioritizes own workload while being proactive and workload of delegated team members
  • Effective communication skills (listening, oral, and written)
  • Strong, sound interpersonal skills, is flexible and adapts to changing situations
  • Organized and proficient at multi-tasking with excellent attention to detail
  • Possesses cross cultural awareness and is able to adapt appropriately
  • Effective organizational and time management skills
  • Ability to work in a team or independently as required
  • Excellent judgment, decision making skills and problem solving ability


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