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Clinical Trial Associate - CA
Ref No.: 18-05894
Location: San Diego, California
Position Type:Full Time/Contract
Start Date / End Date: 09/04/2018 to 03/09/2019
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.*

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
 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.