CRA II/Senior CRA - Oncology, Sponsor Dedicated - Home based Italy
Syneos Health
Home Based, ITA, GB
6 gg fa
source : PharmiWeb.com
  • Clinical Research Associate II / Senior CRA - Sponsor Dedicated, Oncology - Lazio o Campania home based - Up to 10000 ₠ Sign On Bonus!*Come discover what our 25,000+ employees already know : work here matters everywhere.
  • We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.

    As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world.

    Because to us, a patient isn't just a number, they're our family, friends, and neighbors.*Why Syneos Health : *

  • SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
  • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you.
  • That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.

  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
  • Job Responsibilities :
  • Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
  • Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
  • Performs clinical study site management / monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
  • Gains an in-depth understanding of the study protocol and related procedures.
  • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
  • Participates & provides inputs on site selection and validation activities.
  • Performs remote and on-site monitoring & oversight activities using various tools to ensure :
  • Data generated at site are complete, accurate and unbiased
  • Subjects' right, safety and well-being are protected
  • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
  • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study closeout.
  • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits / inspections and overall site performance.
  • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate;
  • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
  • Contributes to CRA team knowledge by acting as process expert, buddy / mentor and sharing best practices as appropriate / required.
  • Supports and / or leads audit / inspection activities as needed.*What We're Looking For : Bachelor's degree or RN in a related field or equivalent combination of education, training and experience* Minimum 1,5 years experience as an independent CRA in possession of CRA Certification according to Ministerial Decree dated 15 / 11 / 2011;
  • Knowledge of Good Clinical Practice / ICH Guidelines and other applicable regulatory requirements* Must demonstrate good computer skills and be able to embrace new technologies* Excellent communication, presentation and interpersonal skills* Ability to manage required travel of up to 50% on a regular basis#LI-VC1*Get to know Syneos Health : *We are the only full-service biopharmaceutical solutions company in the world.
  • That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most.

    Learn more about Syneos Health.*Additional Information : *Tasks, duties, and responsibilities as listed in this job description are not exhaustive.

    The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

    The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

    Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms.

    Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

    The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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