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
Contribute to site activation by:
Assisting with the site staff access to vendor systems
Access reconciliation quarterly
Following-up with sites to ensure staff training completion required by the study, including but not limited to vendor systems
Coordinating the Investigator’s Site File printing and shipment to sites as per the instructions received from the project team
Assisting with the material / equipment shipment to sites
Project maintenance
Contribute to the project management by providing requested data to the clinical project leadership team (e.g. Principal investigator availability, etc…)
Contribute to site maintenance and guarantee inspection readiness by:
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).
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…)
Transfer of documents to sponsor TMF systems (if applicable)
Supporting investigator’s payment management
Address identified site issues and ask guidance to closure, besides to assist the CRAs with the site management issues closure
To assist project teams with trial progress tracking by contributing to ongoing CTMS updates, applicable studies systems and trackers with site information.
Apply working knowledge and judgment to identify potential issues and provide feedback to study teams, as needed
Follow study timelines to ensure successful outcome of the project
Participate in all required applicable trainings
Project Close-out
Follow up on return of equipment by also coordinating with vendors or internal stake holders
Assist the project team (e.g. Clinical Operations Leader and Clinical Research Associate) with database lock activities
With the clinical team guidance, collaborate to ensure that all applicable site management administrative closeout procedures are completed on time and with quality.
Operational
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
Complete routine administrative tasks in a timely manner and with a high degree of proficiency (e.g. timesheets, trainings, assessments and metrics)
Be able to work independently but seek guidance when necessary, escalating issues as required
Active participant as a process and/or platform Subject Matter Expert (SME) with minimal LM oversight.
Skills:
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:
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
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:
Relevant qualification or equivalent experience required
High school diploma or higher – ideally degree in life science or other related background - preferred
