לוח משרות דרושים CRA למחקרים קליניים

In this role you are accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, clients policies and procedures, quality standards and adverse event reporting requirements internally and externally. You would be responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

With the support of exceptional people and an energized purpose, youll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.

In this role you are accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, clients policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, you would be responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Essential Job Duties

Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /other roles.
Executes and oversees clinical trial country submissions and approvals for assigned protocols.
Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
Contributes to the development of local SOPs. Oversees CTCs as applicable.
Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
Collaborates closely with Headquarter to align country timelines for assigned protocols.
Provides support and oversight to local vendors as applicable.
Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.
Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.

In this role you are accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, clients policies and procedures, quality standards and adverse event reporting requirements internally and externally. You would be responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

we are looking for Site Monitor in Israel to strengthen our clinical operations team. Work from home and with the flexibility you want. Our monitors have less travel and less workload to maintain work-life balance. We offer long-term projects, world-class technology and training tailored to your individual experience.As a Site Monitor, will be responsible for data integrity, data quality and ensuring compliance with International Conference on Harmonization and Good Clinical Practice (ICH-GCP) and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. The Site Monitor will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready, will coordinate with institutions and investigators at the local level, and will collaborate with the Study Operations Manager (SOM), Global Study Manager (GSM), and Site Care Partner (SCP).You will have the opportunity to be a unique sponsor dedicated to one of the top 10 pharmaceutical companies in the world, working on oncology studies that deliver real impact.

We are looking for a Clinical Affairs Manager to implement and oversee all activities related to clinical research and clinical studies in the company.
DiA Imaging Analysis provides AI-powered solutions to make ultrasound image analysis smarter and more accessible.
Its AI-based solutions help ultrasound users acquire the right image and analyze it automatically, allowing them to identify clinical abnormalities that are often difficult to find visually and enabling them to make better decisions based on accurate and objective data.
Your role:
Designing and managing the execution of clinical studies that demonstrate medical product safety and efficacy.
Ensuring that trials are conducted in full compliance to GCP.
Full responsibility on sites initiation, site personnel training and monitoring.
Working closely with the principal investigators and study coordinators.
Working with regulatory, development and marketing teams to create scientific publications, clinical marketing material and clinical background required for regulatory submissions.

We are looking for a Clinical Research Associate (CRA) to join our Compliance and Regulatory Affairs (RA) team. Compliance and RA team is responsible for the companys clinical and regulatory activities, quality management systems, and for ensuring compliance with applicable standards.

The team plays a central role in both pre-market and post-market activities. The CRA will play an important role, working with clinical sites, ensuring successful management of clinical activities, and performing assigned monitoring activities throughout the clinical trial lifecycle.



Your responsibilities will include:

Managing global clinical trials at multiple clinical sites, taking part in planning clinical studies, defining clinical protocols, and supporting regulatory documentation.
Collaborating with multiple stakeholders to ensure successful, rigorous, and timely studies.
Proactively managing clinical study processes and monitoring activities. Overseeing and supervising clinical operations to ensure activities are carried in accordance with applicable regulatory requirements and guidelines.
Maintaining strong relationships with external experts to ensure effective execution of clinical studies and research projects.
Taking part in defining and approving clinical study protocols and plans, IRB submission documents, CRFs, and clinical study reports.
Facilitating team training per study protocols and supporting regulatory submission and documentation.