عربي

الصفحة الرئيسية وظائف في مصر وظائف في القاهرة Senior CRA

Senior CRA

TCD MENA

نشرت في 23 أكتوبر 2020

2 - 3 سنوات Cairo - Egypt

أي تخرج. أي جنسية

عدد الشواغر 01

الوصف الوظيفي

ايميل الوظيفة
تم إرسال البريد الإلكتروني بنجاح.

Duties and responsibilities (according to relevant guidelines, laws and procedural documents):
• Gain a thorough knowledge and understanding of the protocol and all relevant sections of associated documents before performing trial related activities.
• Conduct investigational site evaluation, initiation, interim monitoring and close out visits.
• Ensure the required and correctly completed essential documents are in place prior to trial start-up and on an ongoing basis throughout the trial.
• Ensure administrative set-up of sites, laboratories and/or storage facilities, in accordance with trial-specific requirements.
• Organise and participate in investigator meetings as necessary.
• Verify that trial sites are adequately staffed and that relevant trial site team members understand their roles and responsibilities and, in collaboration with the site principal investigator (PI), that the site staff are sufficiently qualified, trained and experienced to complete tasks assigned to them.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol, regulatory and GCP obligations.
• Verify data versus source documentation and validate case report form (CRF) entries. Review data for completeness, medical sensibility, plausibility and accuracy. Generate and resolve queries as required.
• Control investigational product accountability through physical inventory and records review. Verify trial supplies ordering, dispatch, transit processes, storage, dispensing, return and destruction where applicable.
• Document all monitoring activities in the monitoring report, letters and supporting documentation and submit for review within the prescribed timelines.
• Ensure that serious issues and other matters of concern are immediately brought to the attention of the PM, with adequately documented support and follow-up until resolution, in accordance with the relevant SOP and other stipulated processes.
• Provide trial status tracking and progress reports as required by the PM.
• Assist with in-house review of CRFs, query writing and query resolution, CRF tracking, and liaise with data management division for specified trial.
• Conduct and ensure adequate trial close-out and retrieval of trial materials.
• As necessary, assist with the preparation and submission of applications to regulatory, ethics and other relevant authorities.
• Maintain a working knowledge of GCP, Triclinium Procedural Documents and applicable sponsor SOPs.
• Develop management skills and take the necessary initiative to support, advise and guide investigative site staff towards meeting trial objectives.
• Facilitate effective documented communication between investigational sites and the Triclinium project team.
• Facilitate and respond to company and sponsor audits and regulatory inspections.
• Contribute to the project team by mentoring new members, assisting in the preparation of project tools and sharing ideas and suggestions with team members.
• Archive relevant documents as per procedures.


مالية / الخزينة

ملخص المرشح المطلوب

خبره:
• Adequate experience and a proven high level of competency as a CRA with references indicating attributes to meet additional responsibilities of a SCRA.
مؤهلات:
• Bachelor s degree in a scientific or related discipline, licensed or certified health care training.
المهارات والمعرفة:
• Proven clinical trial monitoring skills.
• Thorough knowledge of ICH GCP, SA GCP (if applicable to geographical area), local legal requirements and relevant FDA, EMA and other international guidelines as well as Triclinium Procedural Documents.
• Basic medical and relevant therapeutic area knowledge and understanding of terminology.
• Self-organisation, self-motivation and ability to plan systematically.
• Ability to manage competing demands and to respond cooperatively with shifting priorities.
• Effective oral and written communication skills in English. Knowledge of other regional languages advantageous.
• Effective interpersonal skills in the variety of situations encountered.
• Ability to work in a team or independently as required.
• Ability to mentor team members in a positive and effective manner.
• Team-building skills.
• Ability to effectively communicate with peers, project teams, upper management, sponsor representatives and external healthcare professionals.
• اهتماما قويا بالتفاصيل.
• Diligence in checking own work prior to completion.
• Good computer skills and the ability to learn appropriate software.

الكلمات الرئيسية

Senior CRA

ابلاغ عن هذه الوظيفة

تنبيه: نوكري غلف فقط منصّة يجمع بين كل من الباحثين عن عمل و أصحاب العمل. ننصح المتقدمين للوظائف التحقق من شرعية أصحاب العمل المحتملين. نحن لا ندعم أي مطالبات لتحويل الأموال و ننصح بشدة ضد الإفصاح عن اي معلومات شخصية أو مالية.و ننصح أيضا زيارة تحذير أمني للمزيد من المعلومات. إذا تشك في أي غش أو احتيال اتصل بنا على abuse@naukrigulf.com

TCD MENA


عرض تفاصيل الاتصال

الاتصال

الاسم / التعيين:
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موقع الكتروني https://wuzzuf.net/jobs/p/313934-Senior-CRA-TCD-MENA-Cairo-Egypt


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