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