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Clinical Research Associate (CRA)
Field-based, Jordan
Full-time
2+ years experience
Monitor clinical studies to protect participants, data integrity, and compliance from start-up through close-out.
Clinical Research Associate (CRA)
About the Role
- Monitor clinical studies to protect participants, data integrity, and compliance from start-up through close-out.
Key Responsibilities
- Perform Pre-Study Visits (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV).
- Conduct Source Data Verification (SDV) and manage queries; oversee Investigational Product (IP) accountability.
- Maintain essential documents in Trial Master File (TMF)/electronic TMF (eTMF); ensure adherence to ICH-GCP and local regulations (JFDA).
- Verify safety reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs); confirm informed consent process (ICF).
- Execute risk-based monitoring plans; escalate issues and drive Corrective and Preventive Actions (CAPA) to closure.
- Train site staff on protocol, Electronic Data Capture (EDC), and Good Clinical Practice; coordinate with Clinical Trial Management System (CTMS) stakeholders.
Minimum Qualifications
- Bachelor’s degree or higher in Pharmacy, Nursing, Medicine, or Biomedical/Clinical Sciences.
- 2+ years of on-site monitoring with a CRO/sponsor/site; current GCP training.
- Proficient with EDC, eTMF, and CTMS; strong communication, documentation, and time-management.
Medical Writer (Clinical & Regulatory)
Irbid, Jordan
Full-time
4+ years experience
Produce clear, compliant clinical and regulatory documents across multiple therapeutic areas.
Medical Writer (Clinical & Regulatory)
Role
- Produce clear, compliant clinical and regulatory documents across multiple therapeutic areas.
Key Responsibilities
- Write and quality-check Protocols, Informed Consent Forms (ICF), Investigator’s Brochure (IB), Investigational Medicinal Product Dossier (IMPD), Clinical Study Reports (CSR; ICH E3), and Common Technical Document (CTD) sections.
- Prepare ethics/regulatory submissions to JFDA, EMA, and FDA.
- Ensure end-to-end scientific rigor: conduct targeted literature reviews; align text with SAP, TFLs, eCRFs; manage document control/versioning and author–reviewer workflows.
- Apply Good Publication Practice (GPP 2022) and reporting standards: CONSORT, STROBE, PRISMA.
Qualifications
- Bachelor’s degree or higher in Pharmacy, Medicine, or related field.
- 2+ years clinical/medical writing in pharma/biotech/CRO or academia.
- Strong command of ICH-GCP.
- Excellent scientific English and attention to detail.