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Clinical Trial Associate
Ref No.: 18-12033
Location: San Diego, California
Position Type:Contract
Start Date / End Date: 09/04/2018 to 03/09/2019
Sunrise System Inc. is currently looking for Clinical Trial Associate in San Diego, CA with one of our top client.
Job Title: Clinical Trial Associate
Job Id: 18-12033
Location: San Diego, CA 92121
Duration: 6 months
Position Type: Hourly contract Position (W2 only)
 
Summary
  • The Clinical Trial Coordinator (CTC) is responsible for providing in-house support and assistance to assigned study teams and GTMM.
  • Looking for someone with CRO or pharma experience - at least 2 years in Clinical Operations preferred
  • Please see below for skills/knowledge requirement. 
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 
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
  • 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
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.
  • Conduct additional tasks as may be required by the Clinical Operations Leadership team. 
Key Competencies
  • Responds flexibly to changing business demands and opportunities, proactively looking for ways to
    contribute
  • 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. 
Contact
Praful Prasanna
Email: Praful.P@sunrisesys.com | Direct: (732) 272 0326
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com