Clinical Research Coordinator

GMP Technologies; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

GMP Technologies is seeking a Clinical Research Associate (CRA) specialized in oncology to join its clinical operations team. The role focuses on monitoring, data integrity, and regulatory compliance across sites, with an emphasis on patient safety and trial quality.

The ideal candidate holds a life sciences-related bachelor's degree (advanced degree preferred), at least 1 year of oncology clinical research experience, and solid knowledge of GCP, FDA/ICH guidelines, plus proficiency with MS

Qualifications

• Bachelor's degree in life sciences, nursing, or related field; advanced degree preferred.
• Minimum 1 year of oncology clinical research experience.
• GCP, FDA regulations and ICH guidelines knowledge.
• Excellent organizational and time-management skills.
• Strong communication and teamwork abilities.

Responsibilities

• Monitor clinical trials at investigative sites to ensure adherence to study protocols and regulatory requirements.
• Conduct site initiation, routine monitoring, and close-out visits.
• Review case report forms and source documents for accuracy and completeness.
• Ensure timely data collection, entry and reporting.
• Collaborate with investigators and site staff to address issues.
• Assist in regulatory documents and ethics submissions.
• Maintain study documentation and monitoring reports.

Skills

Oncology experience

GCP Knowledge

Regulatory Knowledge

Communication

Organization

Education

Bachelor's degree in life sciences, nursing, or related field

Advanced degree preferred

Tools

MS Office

CTMS

Job description

About the job Clinical Research Coordinator

Job Title: Clinical Research Associate (CRA) - Oncology

Job Type: Full-time

About Us: Our client is a leading organization dedicated to advancing medical research and improving patient outcomes. Their focus is on developing innovative treatments and therapies, with a strong emphasis on oncology. We are committed to conducting high-quality clinical trials and ensuring the highest standards of scientific integrity.

Job Summary: Currently assisting my client to identify and hire a highly motivated and detail-oriented Clinical Research Associate (CRA) to join the oncology research team. The CRA will be responsible for monitoring and managing clinical trials to ensure compliance with regulatory requirements, study protocols, and Good Clinical Practice (GCP) guidelines. The ideal candidate will have a strong background in oncology, excellent organizational skills, and a passion for contributing to cutting-edge cancer research.

Key Responsibilities:

• Monitor clinical trials at investigative sites to ensure adherence to study protocols, GCP, and regulatory requirements.
• Conduct site initiation, routine monitoring, and close-out visits.
• Review and verify case report forms (CRFs) and source documents for accuracy and completeness.
• Ensure timely and accurate data collection, entry, and reporting.
• Communicate effectively with investigators, site staff, and the clinical research team to address and resolve issues.
• Assist in the preparation and submission of regulatory documents and ethics committee applications.
• Maintain study documentation, including monitoring visit reports, correspondence, and regulatory binders.
• Participate in investigator meetings, training sessions, and other study-related activities.
• Ensure patient safety and the integrity of clinical data throughout the study.
• Assist in the development and review of study protocols, informed consent forms, and other study-related documents.
• Provide regular updates and reports to the Clinical Research Manager/Director.

Qualifications:

• Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred.
• Minimum of 1 year of experience in clinical research, with a focus on oncology.
• In-depth knowledge of GCP, FDA regulations, and ICH guidelines.
• Strong understanding of clinical trial processes and documentation.
• Excellent organizational and time-management skills.
• Exceptional attention to detail and accuracy.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in MS Office and clinical trial management systems (CTMS).