לוח משרות דרושים CRA למחקרים קליניים משרה מלאה

As a CTC, you will provide administrative and technical support to the Project Team. Support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provide administrative support for site activation activities. Aid the development of the critical path for site activation within assigned projects in support of rapid site activations.

A day in the Life:
According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Where applicable, conducts on-site feasibility visits (APAC only).
May support scheduling of client and/or internal meetings.
May review and track of local regulatory documents.
May provide system support (i.e., Activate & eTMF).
May support RBM activities.

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 handles 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 according to 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.

Essential Duties and Responsibilities:
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters using approved business writing standards. Raises observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan.
Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follow-up on findings as applicable. Participates in investigator meetings as vital. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.

We are looking for a Clinical and RA associate.
Primary function of the position
Under the oversight of the CRA manager (CTM) the person ensures compliance of study conduct with ICH/GCP and country regulations, companys policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Roles and responsibilities:
Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gains an in-depth understanding of the study protocol and related procedures.
Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
Performs remote and on-site monitoring & oversight activities using various tools to ensure:
Data generated at site are complete, accurate and unbiased
Subjects right, safety and well-being are protected
Conducts site visits including but not limited to initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Supports and/or leads audit/inspection activities as needed
Following the country strategy defined by CRD and CTM, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities
Whiling to travel abroad including US for sites oversights

We are looking for a Medical writer and Regulatory Affairs associate.
Roles and Responsibilities:
Work with clinical teams and clients to understand the nature of the scientific work that they will be covering.
Assess data or products using medical expertise, and quickly develop expertise in new areas as needed for their writing.
Help to write studies for submissions to the FDA. The writing is also used in publications or medical journals, or for internal company use.
Comprehensive writing of clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
Prepare abstracts, scientific exhibits, posters and verbal presentations.
Help with develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations to be used by a variety of audiences.
Conduct comprehensive literature searches to enhance background understanding, and evaluate and analyze the information which will be written about.
Provide responses to regulatory agencies regarding product information or issues.
Maintain current knowledge of relevant regulations, including proposed and final rules. Help in manage activities such as audits, regulatory agency inspections etc.
Participate in the development or implementation of clinical trial protocols. Preparation and submission of regulatory agency applications, reports, or correspondence.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
Primary function of the position
Clinical scientific knowledge and writing skills to effectively and clearly communicate medical science information in writing. Generally, focus on either scientific medical writing, which includes clinical studies, and regulatory documents, scientific articles or marketing medical writing. Experience in regulatory aspects (RA), help to lead regulatory strategy and provide ongoing regulatory input.