- تجربہ
- 1+ سال
- تنخواہ
- —
- کھلنا
- 1
- پوسٹ کیا گیا
- 2 گھنٹے قبل
- کام کا موڈ
- دفتر میں
- تعلیم
- Bachelor's degree or above in Medical, Pharmacology, Biology, or related field
- اہلیت
- Candidates with a bachelor’s degree or higher in a medical, pharmacology, biology, or related background who also have at least 1 year of CRA experience are eligible. Strong applicants who do not match every stated requirement may still be considered.
- دوبارہ شروع کریں۔
- درخواست دینے کی ضرورت ہے۔
ملازمت کی تفصیل
Job overview
This contract role is focused on end-to-end project coordination and site management for clinical studies in New Zealand. The position covers site selection, start-up, monitoring, and close-out, and must be carried out in line with Tigermed or sponsor SOPs, ICH-GCP, GCP, and other applicable regulations.
The role also carries responsibility for making sure site-generated data is accurate, delivered on schedule, and managed within the approved budget.
Site management
- Support clinical study site selection, initiation, and monitoring activities.
- Carry out pre-study visits to confirm that proposed sites meet sponsor selection criteria, including sufficient capability and relevant experience.
- Plan and lead site initiation visits so site teams receive the training needed to start and run the study in compliance with the protocol and regulations.
- Verify that the Principal Investigator and site personnel follow all safety reporting obligations set out in the protocol, SOPs, ICH-GCP, and GCP.
- Monitor recruitment progress and work to ensure enrollment targets are met across assigned studies.
- Perform monitoring visits according to the SDV plan and SOPs, resolve site issues, and submit monitoring visit reports promptly.
- Coordinate delivery of study materials such as investigational product, non-drug supplies, equipment, and CRFs to sites for startup and ongoing study needs.
- Prepare the site-specific EC submission package and ensure it is submitted correctly.
Training
- Provide regular guidance to site teams on ICH-GCP, GCP, protocol requirements, and study-specific processes.
- Lead site initiation activities to confirm that the site fully understands the protocol and operational expectations.
Documentation
- Collect essential documents on time during study startup, conduct, and close-down, ensuring regulatory and protocol compliance.
- Keep investigator site files and trial master files current and properly organized.
- Complete study record archiving in accordance with sponsor and protocol requirements.
Drug safety
- Share safety updates with all participating sites according to SOPs and relevant regulations.
- Make sure serious adverse events are reported within the required timelines and in line with applicable procedures.
Finance and administration
- Complete budget finalization and secure the signed site contract before the site initiation visit.
- Ensure the study payment schedule is followed and keep the supporting documents and receipts on file.
Study tools and systems
- Keep study tools and systems updated accurately and on time.
Qualifications
A bachelor’s degree or higher in Medicine, Pharmacology, Biology, or a related field is required. Strong candidates may be considered even if they do not fit every listed requirement exactly.
At least 1 year of CRA experience is expected. Applicants should have a solid understanding of Good Clinical Practice and clinical trial operations, along with strong working knowledge of Microsoft Word, Excel, PowerPoint, and Outlook.