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ATTENTION VENDORS: correct Job Title - Clinical Trial Coordinator so please provide it and the JD to the candidates.
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.*
• 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:
• 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
• 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
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.
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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