Clinical Research Coordinator

Clinical Research Coordinator
Empresa:

Jobleads



Área:

Otros

Clinical Research Coordinator

Detalles de la oferta

We are looking for an experienced Clinical Research Coordinator to join one of the most relevant foundations in the field, coordinating the start-up of studies and the progress of clinical protocols from the planning stage through study completion by acting as liaison to the investigators, physicians and participants. Have you been managing clinical trials in Alzheimer's disease or do you feel interested to? then this Clinical Research Coordinator could be you! Job Description: The CRC is responsible for IRB submissions, maintaining trial regulatory binders, assure preparation and realization of audits, data collection, data cleaning, participant’s recruitment, sampling procedures and oversight, research lab oversight, research lab sample processing, patient consenting, protocol compliance, patient follow-up and preparation of documents. The CRC regularly attends meetings of the clinical research team to discuss the current research status, update study staff on enrollment and research related issues and help in the planning of future studies. The CRC also acts as a reference to the rest of the clinical research team (nurses, raters, etc.) and assists the clinical site personnel on efficient high standards operations for conducting quality clinical research. Responsibilities: Clinical research projects: Conduct the clinical researches allocated according to study protocol, BBRC guidelines, ICH (GCPs) and local regulatory procedures. Ensure that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study. Implement work processes and guidelines for optimal clinical research. Coordinates the collection and completion of all required regulatory documents in a timely, accurate, and complete manner prior to study start-up and upon expiration; store in document management system. Implement participant’s recruitment strategies in conjunction with the Clinical Operations Manager. Assure that participant’s visits are schedule within protocol windows. Design procedures to obtain informed consent in accordance with GCP and protocols. Control the maintenance of Clinical Research Essential Document Files and Binders. Communicate with Sponsor/Investigators/research unit team regarding study activities. Guarantee the integrity of Trial Master File (TMF) of each clinical research study. Assure clinical studies high standards of quality: Report all adverse events to the Investigator and serious adverse events to Sponsor/CRO, IRB in accordance with AE/SAE procedures defined by the protocol. Maintain adequate and accurate source documents. Ensure that data is entered in timely and accurately manner into the databases. Work closely to the institution Data Manager to ensure that appropriate quality control systems are in place to monitor the progress of data acquisition and to define new approaches to data management while ensuring quality and completeness of database and participants' files. Responsible to develop and conduct quality control of procedures and tasks to ensure rigorous adherence to internal and external quality standards Design and monitor research team unit indicators. Requirements: Qualifications and professional experience. Bachelor’s degree in science related field. English required (Proficiency Level-written and spoken). Spanish and Catalan, native level. A minimum of 3 years’ experience in clinical research is required (study coordination, research nurse, industry/CRO CRA). In-depth knowledge of clinical trials policies and procedures. Proficient knowledge of human subject research ethics and GCPs. Knowledge of medical and research terminology. Microsoft (MS) Word, Excel and PowerPoint. Excellent verbal and written communication skills: Ability to communicate successfully, both verbally and in writing, to a diverse population. Strong organizational skills, timeliness, and attention to detail are a must. Must be capable of taking initiative to complete all job responsibilities independently and effectively with minimal supervision. Ability to prioritize and manage multiple responsibilities simultaneously. Ability to identify problems and develop solutions for situations that are either analytical or technical in nature. Should demonstrate integrity values and focused on results. Evaluate joining a non-profit organization with a mission of high social impact. Full-time position. Salary will be in accordance with qualifications and experience.


Fuente: Allthetopbananas_Ppc


Área:

  • Otros / Otros

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