Susana Rubí Moral Email & Phone Number

Madrid, Es

Madrid, Comunidad De Madrid, España

Clinical Trial Experience: Phase I Clinical Trials.Therapeutic Experience: Oncology, Onco-hematology.

Madrid, Comunidad De Madrid, España

Sr CRA specialized in Oncology and Phase I Clinical Trials.Clinical FSP on behalf of BeiGene.

Madrid, Comunidad De Madrid, España

Clinical Functional Service Partnerships (Clinical FSP) on behalf of BeiGene

Madrid Y Alrededores, España

Ensure clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements by engaging with assigned sites.RESPONSIBILITIES:- With minimal supervision, may perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions.- Complete… Show more Ensure clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements by engaging with assigned sites.RESPONSIBILITIES:- With minimal supervision, may perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions.- Complete appropriate therapeutic, protocol and clinical research training to perform job duties.- Gain experience in study procedures by working with experienced Site Management staff. May also work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.- With minimal supervision, administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.- With minimal supervision, 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 to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.- With minimal supervision manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.- With minimal supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.- May provide assistance to less experienced clinical staff. Show less

Madrid Y Alrededores, España

Duties: - Collaborating in developing and writing trial protocols, outlining the purpose and methodology of a trial.- Supporting to design data collection forms, as Case Report Forms (CRFs).- Ethic Committee Submission and Notifications.- Performing Regulatory Authority Applications.- Identifying and assessing the suitability of facilities to be used as the clinical trial site.- Identifying/selecting an investigator who will be responsible for the conduct of the trial at… Show more Duties: - Collaborating in developing and writing trial protocols, outlining the purpose and methodology of a trial.- Supporting to design data collection forms, as Case Report Forms (CRFs).- Ethic Committee Submission and Notifications.- Performing Regulatory Authority Applications.- Identifying and assessing the suitability of facilities to be used as the clinical trial site.- Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site.- Liaising with doctors/consultants or investigators on conducting the trial.- Setting up the trial sites, which includes ensuring each centre has the trial materials, including the investigational medicinal product. Plus training the site staff to trial-specific industry standards.- Monitoring the trial throughout its duration, which involve visiting the trial sites on a regular basis (Site Selection, Initiation, Monitoring and Close-Out Visits).- Verifying that data entered on to the CRFs is consistent with patient`s Clinical Records (Source Data Verification: SDV).- Writing Visits Reports and filing and collating trial documentation and reports.- Ensuring all unused trial supplies are accounted for.- Establishing regular lines of communication plus administering protocol and related study training to assigned sites.- Reporting of follow-up.- Managing progress by tracking CRF completion and data query resolution.- Evaluating the quality and integrity of site practices – escalating quality issues as appropriate.- Cooperating/writing in the development of the company standard operating clinical procedures (SOP). Show less

Madrid

Major responsibilities:Conduct on-site visits with experienced CRA mentors to practice monitoring tasks including, but not limited to:- Ensure regulatory and protocol compliance.- Review completion of proper informed consent procedures.- Ensure accurate data reporting via review of site source documents and medical records.- Interpret data to identify protocol deviations and risks to subject safety/data integrity.- Generate queries and manage resolutions with site… Show more Major responsibilities:Conduct on-site visits with experienced CRA mentors to practice monitoring tasks including, but not limited to:- Ensure regulatory and protocol compliance.- Review completion of proper informed consent procedures.- Ensure accurate data reporting via review of site source documents and medical records.- Interpret data to identify protocol deviations and risks to subject safety/data integrity.- Generate queries and manage resolutions with site personnel.- Perform investigational product accountability as per the protocol and Study Monitoring Plan.- Evaluate execution of study protocol at the site level. Use judgement and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.- Document the activities through the follow-up letters, visit reports and other study documents required according to the company's SOP and the Study Monitoring Plan.- Quickly adapt to changing variables to achieve goals and targets. Show less

Alcobendas, Madrid, España

Madrid Y Alrededores, España

Madrid Y Alrededores, España

Madrid Y Alrededores, España

Madrid Y Alrededores, España

Máster Monitorización Ensayos Clínicos Y Medical Affairs - Mmec, Industria Farmacéutica, 8,1

Licenciatura, Farmacia

Bachillerato, Health Services/Allied Health/Health Sciences, General