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الصفحة الرئيسية وظائف تونس Senior Clinical Research Associate Jobs In Tunisia كبير الباحثين السريرية للبحوث

زميل أول للبحوث السريرية (SCRA) - تونس

Phoenix Clinical Research

تم نشره يوم 26 يوليو, 2019

3 - 4 سنوات تونس - تونس

أي جنسية

سهل التطبيق

عدد الشواغر01

الوصف الوظيفي

ايميل الوظيفة
تم إرسال البريد الإلكتروني بنجاح.

Maintains knowledge and ensures compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs, project specific procedures and project scope, budget, etc. (e.g. Project and Monitoring Plan)
Ensures timely completion of role based and project specific trainings
Supports timely selection of qualified investigational sites (with clinical project manager/project team)
Builds strong and lasting relationships with site investigators and site teams/staff
Schedules, plans, prepares for and then performs site monitoring visits according to the monitoring plan and SOPs to ensure appropriate monitoring activities are completed at each onsite or remote visit (e.g. SDV, site staff training, investigator site file review, compliance checks, drug accountability, observational visits, facility review, etc.).
Applies judgment and knowledge to independently resolve sites issues, questions and concerns
Provides timely updates to tracking systems/clinical trial management system (CTMS) as needed
Collects, compiles and reviews new/updated/amended site regulatory package (SRP) documents in collaboration with Clinical Trial Specialists (CTS)/project team on an ongoing basis
Submits to and follows up with site staff on Clinical Site Agreements (CSA) (including budget), and site-specific Informed Consent Forms (ICF)
Provides prepared EC package to the Principal Investigator (PI) for submission and follows up to secure approval where required
Plans and evaluates patient recruitment, reviews and provides updates to applicable project tracking systems
Reviews subject safety data and AEs/SAEs and ensures appropriate follow-up and escalation according to protocol/regulatory requirements
Responds to site issues, ascertains and recommends appropriate follow-up response to issues including potential deficiencies in documentation, communication, and the need for additional training
Evaluates overall compliance and performance of sites and site staff: provides recommendations regarding site-specific actions and uses judgment and experience to assess the ability and motivation of site staff
May assist Project Manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members.
Other duties as needed or required
Supervision Received


The candidate should report to the Line Manager, with regular/close supervision.
Requirements

Bachelor’s degree in a science related field or equivalent certification/licensure from an appropriately accredited institution
Minimum 3 years of experience as CRA (clinical research monitoring experience that provides the required knowledge, skills and abilities and experience mentoring or training others)
Valid Driver’s License where applicable
An equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be considered
Deals with confidential information and/or issues using discretion and judgment
Have high experience in interventional clinical trials
Experience in orphan diseases is a plus

Other Qualifications & Skills
Effective clinical monitoring skills
Excellent understanding and demonstrated application to FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures
Ability to mentor and train other monitors in a positive and effective manner
Ability to evaluate medical research data and proficient knowledge of medical terminology
Excellent interpersonal skills
Strong attention to detail
Effective organizational and time management skills
Proven flexibility and adaptability
Excellent team player with team building skills
Ability to work independently as required
Ability to utilize problem-solving techniques applicable to constantly changing environment
Effective verbal and written communication skills, with the ability to communicate effectively with medical personnel
Good command of English language and grammar
Flexibility to travel


R & D/البحوث والتطوير

الكلمات الرئيسية

التجارب السريرية تجنيد GCP المراقبة السريرية فريق البناء كبير الباحثين السريرية للبحوث السير الذاتية إجراءات التشغيل القياسية الباحث الرئيسي مهارات التعامل مع الآخرين

الدخول للتقدّمسجّل وقدّمقدّم بدون تسجيل

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 زيارةتحذير أمنيللحصول على المزيد من المعلومات.إذا تشك في أي غش أو احتيال, مراسلتنا عليabuse@naukrigulf.com

Phoenix Clinical Research


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الاتصال

الاسم / التعيين:
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موقع الكتروني http://www.phoenix-cr.com/vacancies/#1554103920657-53c0e066-5d11


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