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Ad title:
Clinical Research Associate
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| Provided By:
Arensia Exploratory Medicine
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Published: 13 November
/ Deadline: 13 December
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ARENSIA Exploratory Medicine site of an international company in the field of clinical research with headquarters in Germany offers the position of Clinical Research Associate.
Responsibilities:
** The Clinical Research Associate is responsible for Ensure qualitative and timely performance of work according to the project contract (planning, general management, control) in compliance with ICH-GCP, ARENSIA SOPs, as well as national and international regulations
** Involve, liaise and communicate with ARENSIA personnel from different departments as necessary for a successful trial conduct in collaboration with responsible PM
** Ensure confidentiality of the appropriate information
** Performs monitoring activities per ICH-GCP, ARENSIA or Sponsor SOPs and should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site:
** May act as the main line of communication between the sponsor and the investigator
** Verifies that the investigators and investigator` trial staff are adequately informed about the trial and have adequate qualification and resources and remain adequate throughout the trial period
** Checking the accuracy and completeness of the CRF entries, source documents and other trial-related records against each other
** Assists the trial team in query resolution and communication with Sponsor
** Verifies that the trial team is handling, storing, dispensing, administering, returning/destroying appropriately the investigational product
** Verifies that investigator and investigator`s site staff follow the approved protocol and all approved amendment, if any, perform the specified trial functions in accordance with the protocol and any other written agreement with the sponsor and have not delegated these functions to unauthorized individuals
** Verifying that the investigator provides all the required reports, notifications, and that these documents are accurate, complete, timely, legible, dated, and identify the trial
** Organization of Trial Files (Trial Master File and/or Investigator Site File)
** Determining whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the IRB/IEC, the sponsor, and the applicable regulatory requirement (s)
** Reporting of Monitoring activities as specified in applicable SOPs
** Attendance of investigator meetings
** Regular check if Trial medical monitoring activities (status, query resolution, query tracking) are done in line with requirements
** Regular check of filing of essential documents (Investigator Site File)
** Regular check if AE/SAE reporting in line with requirements
** Assistance during on-site audits if required
** Participate in review and development of internal standard documentation (SOPs, forms, instructions, templates, etc.)
Qualification:
** Bachelor or equivalent degree required, preferably in life sciences, medicine, or a related discipline.
** Minimum of 2-3 years of Clinical Research experience, with at least 1-2 years of experience in CRO or Pharmaceutical/Biotechnology Industry environment.
** Excellent communication, collaboration, and problem-solving skills
** Strong quality orientation including the ability to focus on details.
** good knowledge of local legal requirements/laws and ICH GCP guidelines for conduct of clinical trials.
** Excellent oral and written communication skills
** Fluent oral and written English Language
Interested applicant should send Curriculum Vitae via e-mail on the address: tsiala.kitiashvili@arensia-em.com
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