לוח משרות דרושים CRA למחקרים קליניים, לחיפוש זה נמצאו 18 משרות

we are looking for a FSP Clinical Research Associate I/ Clinical Research Associate II.
As part of our global team, you'll have the opportunity to perform and coordinate different aspects of the clinical monitoring and site management process. As a Clinical Research Associate I, you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.

We have an exciting opportunity for Clinical Research Associate (CRA)!
Summarized Purpose:
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Join Us as a Clinical Trial Coordinator - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, youll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coord, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing CRG personnel, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. Additionally, you may act as a buddy during the onboarding phase and provide training to new staff as needed.

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

We're looking for people who have managed complex technology projects, ideally in healthcare or medical devices. Clinical trial experience and experience working inside pharma partnerships are significant advantages.
Major Duties & Responsibilities
Own end-to-end delivery for assigned programs across pipeline, which may span multiple therapeutic areas, stages of development, and partner-sponsored collaborations.
Manage planning, development, testing, and release of digital protocol features required for clinical and commercial readiness.
Build structured delivery plans covering scope, timelines, risks, and dependencies.
Keep Product, Engineering, QA/RA, Clinical, Medical, Regulatory, CMC, and Therapeutics aligned on requirements, timelines, and deliverables.
Serve as \day-to-day delivery counterpart to pharmaceutical partners: manage joint timelines and deliverables, run partner working groups, and prepare materials for joint steering and governance meetings.
Run cross-team meetings that drive accountability and on-time milestones.
Communicate program status, risks, and mitigation plans to internal leadership and external stakeholders.
Coordinate with external partners, including pharmaceutical partners, CROs, clinical sites, and technology vendors, and manage dependencies where partner decisions affect timelines.
Support preparation of program documentation, training materials, and operational tools.
Ensure delivery processes adhere to QMS and relevant regulatory standards for Software as a Medical Device (SaMD) and clinical studies.