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Clinical Trial Coordinator

New Jersey All, NJ

Post Date: 05/25/2018 Job ID: JN -052018-21700 Job Type: Clinical
Responsibilities will include, but are not limited to, the following:

Project Management:
  • Support study teams in administrative tasks and logistics (i.e. expenses, travel arrangements, meeting set-up including investigator meetings)
  • Create and maintain Study Document Shared Locations for assigned study(ies) on the Central Repository
  • File and maintain the study administrative files locally and send original documents to central TMF; when applicable, ensure electronic filing
  • Support Health Authority inspections and CQA audits as required
  • Maintain and update data as appropriate in study management tools including CTMS, National Clinical Trial Databases, etc. as appropriate
  • Assist with reconciliation of IP at study level in collaboration with IMSC
  • Manage local translations and printing for required local documents
  • Support contract implementation as required
Where applicable:
  • Distribute documents to investigational sites, ECs, or vendors as per requirements and distribute communications and study documents to study teams
  • Support the production, coordination, completeness and accuracy of IRB/EC submissions for in-sourced studies
Study Planning and Conduct
  • Assist with TMF set-up, ongoing quality review, and final reconciliation
  • Assist with collection of appropriate country/site insurance
  • Assist with management of study-level IP shipment to sites as necessary
  • Support the development/coordination of study training materials
  • Support the collection and tracking of study documentation as necessary
  • Assist with compilation of Clinical Study Report appendices and close out of studies
  • Assist with granting / removing systems and SharePoint accesses
  • Support the study specific training matrix
  • Manage site file binders activities for in-sourced studies
  • Submit documents to TMF/eTMF
  • Assist with SUSAR listings
  • Assist with or manage TMF QC
  • Search, execute, track CDAs
  • Distribute IBs, ICFs, Protocols, communications, etc. to sites
  • Enter data into CTMS system
  • Set up study team meetings, study launch meetings, meeting minutes
  • Additional responsibilities may include, but are not limited to, the following:
  • Provide general administrative and coordination support to the clinical operations department and the development and continuous improvement of departmental procedures
  • Organize/maintain administrative activities/systems to support department members including compiling, analysis, tracking, filing and other functions as required
  • Open, sort and distribute mail, fax documents, keep files, order office supplies and maintain supplies
  • Responsible for scheduling, organizing, and coordinating logistics for on- and off-site staff meetings
  • Responsible for logistics of meetings with internal and external partners, including scheduling meetings and hosting the visitors
  • Coordinate agenda for, schedule and organize (including conference dial in) meetings as required
  • Manage staff calendars, updating monthly schedule, and arrange travel itinerary and related activities
  • Prepare presentation materials
  • Schedule interviews for candidates
Skills/Knowledge Required:
  • Good written and oral communications skills with understanding of written and oral English
  • Excellent organizational and administrative skills
  • Self-starter and proactive self-learner
  • Ability to multi-task effectively and prioritize assignments from multiple sources
  • Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, Powerpoint, Outlook (ability to manage calendars/inboxes)
  • SharePoint experience a plus
  • Strong Knowledge of regulatory documents, study design
  • Experience filing study documents, and conducting QC/reviews
  • Experience supporting study teams, awareness of what role functional team members play on a study team and general understanding of the tasks the functions handle - data management - safety, science, IMSC, IVRS, etc.
  • Experience with IP reconciliation
  • Ability to work with limited day to day supervision
  • Ability to function productively in a fast paced and rapidly changing environment
  • Able to resolve routine problems independently
Key Competencies:
  • Responds flexibly to changing business demands and opportunities, proactively looking for ways to
  • Uses different communication methods appropriately (e.g., email, voice mail, face-to-face)
  • Learns from both successes and failures
  • Continually works to improve products, services, and work processes
  • Identifies and/or supports new solutions, opportunities, and initiatives
  • Maintains high quality while meeting deadlines and commitments
  • Hold self-accountable for actions and results
  • Ability to work with limited day to day supervision
  • Ability to function productively in a fast paced and rapidly changing environment
  • Able to resolve routine problems independently
  • Works with team members to solve problems and escalate to management appropriately

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