Study Coordinator

Private Advertiser; Penang; On-site; MYR 45,000 - 73,000; Full time

Job summary

Private Advertiser in Penang, Malaysia is seeking a Study Coordinator to manage day-to-day clinical research activities, ensuring studies follow the protocol, GCP, regulatory requirements and the organisation's SOPs. You will work closely with the PI, research team, sponsors, CROs, laboratories and participants to drive accurate, timely execution.

This role requires a Diploma or Bachelor’s degree in Nursing, Biomedical Science, Medical Science, Pharmacy or Life Sciences, knowledge of clinical

Qualifications

• Diploma or Bachelor’s degree in Nursing, Biomedical Science, Medical Science, Pharmacy, Life Sciences or related discipline.
• Knowledge of clinical research processes and ICH-GCP principles preferred.
• Good organisational and time-management skills and attention to detail.
• Proficient in Microsoft Office applications.
• Ability to communicate professionally with study participants, investigators, sponsors, CROs, and healthcare professionals.

Responsibilities

• Coordinate day-to-day activities of assigned clinical research studies.
• Review study protocols, Investigator's Brochure, study manuals and related documents.
• Coordinate study visits and ensure procedures follow the approved protocol.
• Maintain study schedules, recruitment records, screening logs and enrolment records.
• Assist PI and team to ensure timely completion of study activities.
• Monitor progress and flag deviations or delays to the PI or Clinical Operations Manager.
• Assist with identifying, screening and recruiting eligible participants.
• Coordinate participant appointments and follow-up visits.
• Maintain ISF and other study files per requirements.
• Ensure handling, processing, storage and shipment of samples per protocol.

Skills

Time management

Communication skills

Attention to detail

MS Office

Team player

Education

Bachelor’s or Diploma in Nursing/ Biomedical Science/ Medical Science/ Pharmacy/ Life Sciences

Tools

Microsoft Office

Job description

The Study Coordinator is responsible for the day-to-day coordination and administration of clinical research studies in accordance with the study protocol, Good Clinical Practice (GCP), applicable regulatory requirements, and the organisation's Standard Operating Procedures (SOPs). The Study Coordinator works closely with the Principal Investigator (PI), research team, study participants, sponsors, Contract Research Organisations (CROs), laboratories, and other relevant parties to ensure that clinical studies are conducted efficiently, accurately, and within the required timelines.

Key responsibilities

• Coordinate and manage the day-to-day activities of assigned clinical research studies
• Review study protocols, Investigator's Brochure, study manuals, and other study-related documents
• Coordinate study visits and ensure all study procedures are conducted according to the approved protocol
• Maintain study schedules, recruitment records, screening logs, enrolment records, and other study trackers
• Assist the Principal Investigator and research team in ensuring timely completion of study activities
• Monitor study progress and highlight any issues, deviations, or delays to the PI or Clinical Operations Manager
• Assist with identifying, screening, and recruiting eligible study participants
• Coordinate participant appointments and follow-up visits
• Maintain Investigator Site Files (ISF) and other study files in accordance with applicable requirements
• Ensure appropriate handling, processing, storage, and shipment of clinical research samples according to the study protocol and laboratory manual

About you

• Diploma or Bachelor's Degree in Nursing, Biomedical Science, Medical Science, Pharmacy, Life Sciences, or a related discipline
• Prior experience in clinical research, clinical trial coordination, healthcare, laboratory, or a related field is preferred
• Knowledge of clinical research processes and ICH-GCP principles
• Good organisational and time-management skills
• Good written and verbal communication skills
• Attention to detail and ability to maintain accurate documentation
• Ability to communicate professionally with study participants, investigators, sponsors, CROs, and healthcare professionals
• Proficient in Microsoft Office applications
• Ability to work independently and as part of a multidisciplinary team