Clinical Research Specialist
5 days ago
We are seeking a highly skilled and motivated Clinical Research Specialist to join our team. The successful candidate will be responsible for supporting the conduct of clinical research studies, ensuring compliance with regulatory requirements and providing exceptional support to investigators.
Key Responsibilities:
- Liaise with Principal Investigators (PIs) and site-PIs to ensure smooth study conduct;
- Coordinate with various departments for clinical research procedures, including Specialist Clinics, Laboratory, wards, etc.;
- Ensure adherence to protocol procedure and maintain accurate records;
- Screen and recruit suitable candidates as research participants and obtain informed consent in accordance with ICH GCP guidelines and HBRA requirements;
- Explain protocols to research participants and schedule appointments within the required time frame;
- Perform centrifuge blood specimens and send them to laboratory for analysis;
- Trace and return case notes, blood results, and other required documents to patients;
- Collect and analyze data, and perform research procedures as necessary;
- Maintain documentation of patient reimbursement logs and electronic case report forms;
- Identify, document, and submit protocol deviations to Institutional Review Board (IRB) according to hospital and sponsor procedures;
- Inform PIs and collaborators on any adjustments based on protocol changes;
- Complete, report, and follow up on unanticipated problems involving risk to subjects and adverse events or serious adverse events;
- Work with in-house Research Database IT Specialist on extraction of patient medical records and data mining;
- Travel to research participants' homes as needed.
Requirements:
- Minimum Diploma in Biomedical Science or equivalent qualification;
- Experience as a Research Assistant is preferred but not essential.
Skills:
- Machine Learning skills;
- Cell culture techniques;
- Psychology knowledge;
- Data Analysis expertise;
- Clinical Research experience;
- Medicine background;
- Recruiting skills;
- Protocol understanding;
- Data Mining abilities;
- Python programming skills;
- Molecular Biology knowledge;
- Screening techniques;
- Medical Records management.
Benefits:
The successful candidate will enjoy a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.
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