At a glanceSummarised by Seekless from the posting.
Must have15
Strong computer skills including knowledge of Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
Good organizational skills, ability to manage multiple tasks and meticulous attention to detail
Maintain a basic knowledge and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations and applicable Parexel procedures
Good oral and written communication skills
Flexibility to perform multiple tasks and ability to prioritize these to achieve project timeline
High commitment to and performs consistently high-quality work
Effective problem-solving skills
Mentor and train less experienced staff as appropriate
Demonstrate attitude, teamwork, proactiveness and confidence
Good learning ability
Action oriented
A flexible attitude with respect to assignments and new learning
Strong command of written and spoken English language
Local language proficiency as required
Relevant qualification or equivalent experience
Nice to have4
Proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word, Power Point, Outlook, WebEx
Experience in office management in an international environment
Previous clinical research experience (e.g. Study Coordinator, Clinical Trial Assistant, etc.)
High school diploma or higher – ideally degree in life science or other related background
Skills
Clinical Trial Management System (CTMS)
Electronic Document Management System (EDMS)
Excel
Word
PowerPoint
Outlook
WebEx
Electronic Data Capture (EDC)
When our values align, there’s no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.
Key Accountabilities:
Project Initiation & Planning
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Contribute to site activation by:
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Assisting/ with the site staff access to vendor systems
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Access reconciliation quarterly
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Following-up with sites to ensure staff training completion required by the study, including but not limited to vendor systems
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Coordinating the Investigator’s Site File printing and shipment to sites as per the instructions received from the project team
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Assisting with the material / equipment shipment to sites
Project maintenance
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Contribute to the project management by providing requested data to the clinical project leadership team (e.g. Principal investigator availability, etc…)
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Contribute to site maintenance and guarantee inspection readiness by:
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Managing with quality the Trial Master File (TMF), which includes, but is not limited to: upload documents on time, assist with the update of the Expected Document List (EDL) on and ongoing basis and take the applicable actions to prevent and resolve Quality Issues (QIs).
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Follow up with site staff members and internal study team members regarding pending documents, needed information or pending actions (e.g. trainings to be completed, data to be added to the Electronic Data Capture (EDC), verification of safety information, etc…)
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Transfer of documents to sponsor TMF systems (if applicable)
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Supporting investigator’s payment management
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Address identified site issues and ask guidance to closure, besides to assist the CRAs with the site management issues closure
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To assist project teams with trial progress tracking by contributing to ongoing CTMS updates, applicable studies systems and trackers with site information.
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Apply working knowledge and judgment to identify potential issues and provide feedback to study teams, as needed
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Follow study timelines to ensure successful outcome of the project
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Participate in all required applicable trainings
Project Close-out
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Follow up on return of equipment by also coordinating with vendors or internal stake holders
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Assist the project team (e.g. Clinical Operations Leader and Clinical Research Associate) with database lock activities
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With the clinical team guidance, collaborate to ensure that all applicable site management administrative closeout procedures are completed on time and with quality.
Operational
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Maintain a working knowledge and ensure compliance with applicable ICHGCP Guidelines, local regulatory requirements and Parexel WSOPs, SOPs, Operational Guidelines, Work Instructions and study specific procedure
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Complete routine administrative tasks in a timely manner and with a high degree of proficiency (e.g. timesheets, trainings, assessments and metrics)
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Be able to work independently but seek guidance when necessary, escalating issues as required
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Active participant as a process and/or platform Subject Matter Expert (SME) with minimal LM oversight.
Skills:
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Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
•
Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
•
Maintain a basic knowledge and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations and applicable Parexel procedures
•
Good oral and written communication skills
•
Flexibility to perform multiple tasks and ability to prioritize these to achieve project timeline
•
High commitment to and performs consistently high-quality work
•
Effective problem-solving skills
•
Mentor and train less experienced staff as appropriate
•
Demonstrate attitude, teamwork, proactiveness and confidence.
•
Good learning ability
•
Action oriented
•
A flexible attitude with respect to assignments and new learning
Knowledge and Experience:
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Strong command of written and spoken English language, local language proficiency as required
•
Proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word, Power Point, Outlook, WebEx would be advisable
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Experience in office management in an international environment would be advisable
•
Previous clinical research experience (e.g. Study Coordinator, Clinical Trial Assistant, etc…) – preferred
Education:
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Relevant qualification or equivalent experience required
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High school diploma or higher – ideally degree in life science or other related background - preferred