לוח משרות דרושים CRA למחקרים קליניים משרה מלאה

The internship program provides learning experience, mentoring and valuable work experience in the field of clinical trials. We provide our interns the opportunity to work on meaningful assignments and make sure that they gain real world experiences (in the areas of Regulatory & Finance and Supply & CRA support).



This program provides comprehensive trial and site administration experience. Under the oversight of the COM Lead/COMs and CTCs, the person prepares, collates, distributes and archives clinical documents. The Interns supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

* Internship duration up to 12 months *

Responsibilities:

Trial and site administration:

Track (e.g. essential documents) and report (e.g. Safety Reports)

Ensure collation and distribution of study tools and documents

Update clinical trial databases (CTMS) and trackers

Clinical supply & non-clinical supply management, in collaboration with other country roles

Manage Labeling requirements and coordinate/sign translation change request

Document management:

Prepare documents and correspondence

Collate, distribute/ship, and archive clinical documents, e.g. eTMF

Assist with eTMF reconciliation

Execute eTMF Quality Control Plan

Update manuals/documents (e.g., patient diaries, instructions)

Document proper destruction of clinical supplies.

Prepare Investigator trial file binders

Obtain translations of documents

Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions

Obtain, track and update study insurance certificates

Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.

Publish study results for GCTO and RA where required per local legislation

We are seeking a Clinical Operation Manager to oversee and manage the execution of clinical trials, ensuring compliance with regulatory requirements and alignment with company objectives. This role is pivotal in coordinating clinical operations, supporting global clinical trial execution, vendor management, and data integrity to facilitate successful regulatory submissions.

The Clinical Operation Manager will work closely with internal teams, CROs, regulatory bodies, and external partners to ensure that all clinical trials are conducted efficiently and in compliance with FDA and international regulations.

Key Responsibilities
In collaboration with Head of clinical operations and/or Medical Director,
responsible for comprehensive study management
Lead core team meetings for assigned studies, ensuring goals and deliverables are defined, and issues, decisions, risks, and actions are appropriately tracked
Responsible for managing project-specific vendors, including Study Committees, CRO/ARO, Core Labs, and DSMBs/CECs.
Oversee and support the development of key study documents including, but not limited t,o study protocols and related amendments, study plans and procedure manuals, project tools, training materials, Informed Consent Forms, and Clinical Study Reports.
Accountable for the conduct of clinical study following the approved project plans, budgets, SOPs, and applicable regulations
Support analysis and development of action plans for investigational sites, vendor management, non-compliance, and administrative issues

We are looking for a nonclinical lead with a toxicology and nonclinical drug development background to join our team. The role involves managing all nonclinical studies, scientific review of study plans, regulatory document review and writing, and participation in strategic discussions.

Key Responsibilities
Management and monitoring of all non-clinical studies
Review and oversee nonclinical studies Provide expert evaluation and guidance on nonclinical study plans and reports.
Regulatory support Review regulatory documents as a nonclinical SME and contribute to regulatory writing (IB, submission documents) as needed.
Strategic input in nonclinical development Offer expert guidance on nonclinical development strategies.
Participation in team meetings provide updates on study monitoring
Expert consultation Take part in dedicated expert meetings as needed.

Join our dedicated Clinical Research team as a Clinical Research Associate (CRA). In this role, you will have local responsibility for the delivery of studies at allocated sites and will be an active participant in the local study team(s). You will work in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. This is your chance to strengthen our pipeline and make a meaningful impact on patients' lives!

Accountabilities:
As a CRA, you will contribute to the selection of potential investigators, train, support and advise Investigators and site staff in study-related matters, and ensure that study sites are inspection ready at all times. You will also be responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, ensuring compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations.

If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then we challenge you to live up to your potential by joining us at SCRA, home-based, Isreal.We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.As the company that conducts vital clinical studies for sponsors, including the world's leading biotechs and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects.Our CRAs work from their home office base, supporting studies within their country or region. Manageable sites, manageable protocols is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.The most significant aspect of this position is that You will be dedicated to a single client You will be responsible for all site management and supervisory activities in the assigned oncology studies. You will work with industry leaders and subject matter experts. You will have the opportunity to mentor junior CRAs. You will work with world-class technology. You will have great opportunities to travel, work from home, meet new people and play a key role in the drug development process.Our people and their passion are very important to us as they are the key to our success. That's why we provide you with an open and friendly working environment where we empower people and provide them with opportunities to develop their careers in the long term. In addition, you will have the opportunity to develop within your role and take on more responsibility or develop your skill set within other related our company's departments.

Are you ready to lead and inspire? As a Local Study Associate Director (LSAD), you will lead Local Study Teams (LSTs) at the country level to deliver clinical studies within agreed resources, budget, and timelines. You will ensure compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. In addition to leading LSTs, you may perform site monitoring as needed to support the flexible capacity model. Your role will be crucial in identifying sites, performing site qualifications, setting up, initiating, monitoring, closing, and archiving documentation.

Accountabilities
Overall responsibility for study commitments within the country and timely delivery of data to required quality.
Lead Local Study Team consisting of CRA(s), CSA(s) for assigned study/studies.
Optimize the performance of Local Study Team(s) ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations.
Ensure high-quality clinical and operational feasibility assessments of potential studies.
Coordinate site selection by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits.
Ensure timely submission of application/documents to EC/IRB and Regulatory Authority.
Prepare and maintain accurate study budgets in AZ clinical studies financial system.
Prepare local Master CSA (including site budget) and amendments as needed.
Prepare country level Master Informed Consent Form (MICF) and subsequent site level ICFs.
Collect and verify trial essential documents prior to study start.
Plan and coordinate local drug activities.
Set up and maintain the study in CTMS at study country level.
Oversee monitoring activities from site activation through to study closure.
Review monitoring visit reports and advise monitors on study-related matters.
Perform co-monitoring, Accompanied Site Visits/training visits with study CRAs.
Identify risks and facilitate resolution of complex study problems.
Organize regular Local Study Team meetings.
Maintain good personal relationships with all Local Study Team members, sites staff, and global stakeholders.
Report study progress/update to the Global Study Associate Director/Global Study Team.
Contribute to patient recruitment strategy.
Develop and review risk management plan on country study level.
Communicate regularly with National Co-ordinating Investigator/National Lead Investigator on recruitment and other study matters.
Plan and lead National Investigator meetings. Assist in forecasting study timelines, resources, recruitment, budget, study materials, and drug supplies.
Ensure relevant systems are set-up, updated, and access is organized at country level.
Ensure accurate payments related to the study are performed according to local regulations and agreements.
Participate in training and coaching new members of the Local Study Team.
Ensure completeness of the eTMF and maintain it Inspection Ready.
Ensure all study documents are ready for final archiving and completion of local part of the eTMF.
Plan and lead activities associated with audits and regulatory inspections.
Provide input to process development and improvement.
Provide regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
Update Line Managers about the performance of the CRAs/CSAs.
Ensure compliance with local policies and code of ethics.
Provide feedback on research-related information useful for the local market.
Collaborate with local Medical Affairs team.
Support SMM in different initiatives as agreed with SMM Line Management.