Clinical Operations Assistant (CTA)

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