Clinical Research Associate II (CRA II) or Senior Clinical Research Associate (SCRA)

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance with a quality-focused collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Clinical Research Associate (CRA II or Senior CRA) on a permanent basis.  You will be responsible for site management (including start-up) both on-site and remotely across Italy while working on projects from our varied client base ranging from small to big pharmaceutical biotechnology medical device and consumer health companies.

Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

• Keep professionally abreast of all scientific regulatory and operational aspects relevant to the clinical projects assigned.

• Assist in the selection of sites site evaluation visits initiation visits and ensure follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.

• May act as Feasibility Associate.

• Train site staff in all study procedures.

• Conduct periodic monitoring visits including completion of monitoring visit report. Review at each visit the accuracy legibility completeness and quality of the Case Report Forms (CRF).

• Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data.

• Manage the investigational products (storage inventory dispensing records packaging and labelling) and the trial material (Investigator Study File (ISF) CRF questionnaires diaries etc.) to ensure timely and correct supply to the site.

• Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs SAEs SUSARs etc.) and their follow-up guaranteeing timely and appropriate handling of safety issues.

• Conduct and report study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.

• Act as the main contact person for the site in order to ensure close follow up.

• Provide general support to the Clinical Research Division on quality control of clinical data.

• Address appropriate team members about any issues that can jeopardise the conduct of the clinical projects assigned in a timely manner.

• Report to the Head of department on all activities performed during the study and send all relevant documents according to the timelines and the requirements agreed for each single clinical trial.

• Develop training material and give training in collaboration with the Training & Qualification Management Unit.

• May assist with contract negotiation with sites on study budget after appropriate training.

• Assist with the preparation of the study including CRF design/development write CRF instructions and organise the study files and documents to ensure good start-up of the investigation sites.

• May support the submission process in the project including submission requirements timelines informed consent development etc..

• Guide and supervise Clinical Research Associate I (CRA I) in order to coach and train them on the job.

Education Experience and Skills:

• University Degree in scientific medical or paramedical disciplines.

• Proven experience as a CRA performing on-site monitoring activities.

• Strong knowledge of clinical trial operations GCP/ICH Guidelines and other applicable regulatory requirements.

• Fluent in English and local language(s).

• Proficiency in Microsoft Office (e.g. Word Excel Outlook).

• Willingness to travel.

The Benefits of Working in Italy:

• Meal vouchers

• Competitive salary

• Excellent work-life balance

• Dedicated Line Manager

• Full performance and development process with end of year reviews

• Team events and end of year party

• Career opportunities within ClinChoice locally and globally

• Employee satisfaction survey – your feedback is important for continuous improvement

The Application Process

Once you have submitted your CV you will receive an acknowledgement that we received it. If you have the requirements we need you will be invited for phone interview as the first step.  Unfortunately due to the number of applications we receive we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical biotechnology medical device and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4000 professionals in more than 20 countries across the Americas Europe and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting developing and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender race beliefs and ethnicities. We recognize this is our strength and celebrate it.

Key words: Clinical Research Associate CRA Site Management Site Manager Monitor Monitoring Oncology Respiratory Medical Devices Cardiology Travel Submissions Ethics CRO Contract Research Organisation Outsourced Outsourcing Sponsor-dedicated

#LI-CM1 #LI-Remote #Fulltime