Clinical Operations Assistant - Malaysia

PAREXEL APEX International Co., Ltd.; Selangor; On-site; MYR 39,000 - 61,000; Full time

Job summary

Parexel APEX International Co., Ltd. is seeking a Clinical Operations Assistant to support project teams in Malaysia. You will handle site activation tasks, TMF maintenance, and data tracking to ensure trial quality and timeliness within a global CRO environment.

The role requires strong organizational and communication skills, familiarity with CTMS/EDMS, and a proactive approach to compliance with ICH-GCP and Parexel SOPs. Japanese language ability is required.

Qualifications

• Strong command of written and spoken English; local language skills as required.
• Experience in clinical research or office management in an international environment is advisable.
• Knowledge of ICH-GCP guidelines and Parexel procedures preferred.

Responsibilities

• Assist site activation: access vendor systems and coordinate staff training.
• Maintain the Trial Master File (TMF) and update the EDL; resolve QA issues.
• Transfer documents to sponsor TMF systems as applicable.
• Support investigator payments and site issue resolution.
• Track trial progress in CTMS/EDC; update trackers with site data.
• Engage in study trainings and ensure timelines are met.

Skills

CTMS

EDMS

MS-Office

English proficiency

Japanese language

Organizational skills

Communication skills

Problem-solving

Teamwork

Education

High school diploma or higher – life science background preferred

Tools

CTMS

EDMS

MS-Office Suite

Job description

Clinical Operations Assistant - Malaysia

The role of the Clinical Operations Assistant (COA) is to complete administrative tasks on behalf of assigned Project Clinical Team member which might include site management tasks during the different phases of a clinical trial as startup, maintenance and termination, contributing to the efficiency, accuracy, and quality of the trials.

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
• Japanese language skill is required

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

• High school diploma or higher – ideally degree in life science or other related background - preferred

Parexel is one of the world's largest clinical research organizations (CROs), providing Phase I-IV clinical development services to speed lifesaving treatments to patients. With over 21,000 professionals worldwide, we partner with biopharma leaders and innovators to design and deliver patient-focused trials, making clinical research accessible. For 40 years, we've advanced research in complex healthcare areas, offering innovative, efficient trial solutions. Recognized as a top CRO, Parexel won “Best CRO” by Citeline, “Top CRO to Work With” by WCG CenterWatch, and the 2023 SCRS Eagle Award for advancing clinical research.

Parexel is one of the world's largest clinical research organizations (CROs), providing Phase I-IV clinical development services to speed lifesaving treatments to patients. With over 21,000 professionals worldwide, we partner with biopharma leaders and innovators to design and deliver patient-focused trials, making clinical research accessible. For 40 years, we've advanced research in complex healthcare areas, offering innovative, efficient trial solutions. Recognized as a top CRO, Parexel won “Best CRO” by Citeline, “Top CRO to Work With” by WCG CenterWatch, and the 2023 SCRS Eagle Award for advancing clinical research.