Clinical Research Coordinator

Private Advertiser; Petaling Jaya; In loco; MYR 67.000 - 100.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive remuneration package

Opportunities in oncology trials

Direct exposure to investigators and S

Professional development opportunities

Collaborative work environment

Descrizione del lavoro

Private Advertiser seeks an experienced Study Coordinator to join a newly established clinical research unit focused on oncology studies. You will coordinate trials, support operations, and help implement efficient workflows in a growing environment.

You will collaborate with investigators, teams, and sponsors to ensure studies run ethically and in compliance with regulatory requirements. Oncology experience is a plus.

Competenze

• Bachelor's degree in a healthcare discipline as a minimum requirement.
• Experience as a Study Coordinator or in clinical research is strongly preferred.
• Experience in oncology clinical trials is an asset.
• Familiarity with ICH-GCP guidelines and regulatory requirements.
• Strong organizational, communication, and problem-solving abilities.
• Proactive and able to work independently in a developing environment.

Mansioni

• Coordinate day-to-day clinical trial activities from start-up through close-out.
• Collaborate with Principal Investigators, research teams, sponsors, and CRAs.
• Coordinate patient screening, recruitment, informed consent, and visits.
• Maintain Investigator Site Files, source documents, and eCRFs.
• Ensure compliance with study protocols, GCP, and regulatory requirements.
• Support site initiation, monitoring visits, audits, and inspections.
• Track milestones, recruitment, and outstanding activities to ensure timely completion.
• Assist in developing workflows for the new unit.

Conoscenze

Organizational skills

Communication skills

Problem-solving

Formazione

Bachelor's Degree in Nursing, Biomedical Science, Life Sciences, or related healthcare discipline

Descrizione del lavoro

We are seeking an experienced and proactive Study Coordinator to join a newly established clinical research unit, with a focus on oncology studies. As part of a growing research unit, you will play an important role in coordinating clinical trials, supporting research operations, and establishing efficient study workflows. You will work closely with Principal Investigators, clinical teams, and industry sponsors to ensure studies are conducted efficiently, ethically, and in compliance with applicable regulatory requirements.

Key responsibilities

• Coordinate day-to-day clinical trial activities, from study start-up through close-out
• Work closely with Principal Investigators, research teams, sponsors, and Clinical Research Associates (CRAs)
• Coordinate patient screening, recruitment, informed consent processes, and study visits
• Maintain accurate study documentation, including Investigator Site Files (ISF), source documents, and Case Report Forms (eCRFs)
• Ensure compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements
• Support site initiation visits, monitoring visits, audits, and inspections
• Track study milestones, patient recruitment, and outstanding activities to ensure timely completion
• Assist in developing and improving workflows and operational processes for the new research unit

Who we're looking for

• Bachelor's Degree in Nursing, Biomedical Science, Life Sciences, or a related healthcare discipline
• Prior experience as a Study Coordinator or in clinical research is strongly preferred, particularly in industry-sponsored clinical trials
• Experience in oncology clinical trials will be an added advantage
• Familiarity with ICH-GCP guidelines, clinical trial documentation, and regulatory requirements
• Strong organizational, communication, and problem-solving skills
• Proactive, adaptable, and resourceful, with the ability to work independently and take ownership of assigned studies
• Comfortable working in a newly established research environment where processes and workflows are still being developed
• Able to manage multiple studies, prioritize competing deadlines, and respond effectively to changing operational needs

What We Offer

• Competitive remuneration package commensurate with experience
• Opportunity to work on industry-sponsored clinical trials, particularly in oncology
• Direct exposure to experienced investigators, clinical research professionals, and industry sponsors
• Professional development and opportunities to expand clinical research expertise
• Collaborative working environment with opportunities to contribute ideas and improvements