Clinical Research Associate II / Sr. CRA, Italy

Rho

  • Italia
  • Tempo indeterminato
  • Full time
  • 1 mese fa
Job Description:Rho, an award-winning, stable, full-service CRO known for its collaborative, dynamic culture based in the US, is quickly expanding their presence in Europe. We are a thriving company, and we will deliver global full-service clinical development services and unmatched customer support - worldwide.Join us in redefining what it means to work for a CRO. Working at Rho, you'll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity's biggest challenges.At Rho, we believe in the power of passionate individuals working together to make a difference in clinical research. As a Clinical Research Associate II / Sr. CRA, you will be a key player in our innovative team, dedicated to ensuring that our clinical trials are conducted with the utmost integrity and quality. Your expertise will help us navigate the complexities of clinical research as we strive to deliver meaningful solutions to healthcare challenges.The Clinical Monitoring team at Rho is known for its collaborative spirit and commitment to excellence. Join us to not only advance your career but also contribute to a culture that celebrates innovation, supports professional growth, and values every team member's input.This is a permanent CRA II / Senior CRA role to be home based role in Italy.Responsibilities:
  • May contribute to the development of study tools and materials as well as documentation for clinical trials
  • May provide mentoring, training, and co-monitoring of junior CRAs and other clinical team members
  • May provide support to the RFP process
  • Prepare and perform all onsite & off-site/remote site monitoring visit activities across multiple protocols, inclusive of all study visit types as needed (SQV, SIV, IMV and COV), according to Good Clinical Practice(GCP), Protocol, applicable regulations and Sponsor requirements under supervision of experienced staff
  • Effectively documents observations in site visit reports and follow up letters within timelines required by Rho's procedural documents and the applicable clinical monitoring plan
  • Prepare (if needed) and maintain Investigator Site Files (ISF), and maintain site binders and documents of the TMF (Trial Master
  • May assist in payment processes, including liaison with Site and review Site and patient data for visits being invoiced
  • Assist in the appropriate identification and action of AE (Adverse Event), SAEs (Serious Adverse Event) and pregnancy reporting procedure
  • Verify and confirm appropriate IMP (Investigational Medicinal Product) handling at Site and perform drug accountability
  • Help to plan and perform Country and Site Feasibility, including assessment of potential Risks and challenges, as well as select Study sites and perform pre-study visits
  • Assist in selection of Study specific Vendors and perform Vendor assessments
  • Support in negotiation and execution of Investigator/ Institution contracts
  • May help to prepare documents submission to Ethics Committee, Competent Authorities and other bodies (as applicable), including communication with Sponsor, EC/ CA and other involved parties
For Senior CRAs:
  • Provide mentoring, training, and co-monitoring of junior CRAs and other clinical team members.
  • May support Clinical Team Lead and Project Management tasks on assigned studies as-requested (e.g. study specific process development, trip report review, newsletter creation, leading CRA project team calls, etc.)
  • May conduct sign-off visits to assess competency of other CRAs
  • May attend and present at meetings and conferences, including Investigator Meetings
  • May participate in the interview and selection process for CRAs
Requirements:
  • Bachelor's degree, preferably in a life science, nursing, pharmacy, or related science field
  • Registered Nursing certification or equivalent or relevant formal academic / vocational qualification (such as LPN) combined with a minimum of 2 years of clinical monitoring experience and demonstrated clinical monitoring knowledge may be considered in lieu of a Bachelor's degree
  • 2 years of on-site monitoring experience within the CRO, pharmaceutical or biotechnology industry
  • Fluent in English and local language
  • Proficient knowledge of ICH-GCP and country specific clinical monitoring guidelines
  • Proven clinical monitoring skills
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology in areas of experience
  • Average travel is expected to be 80% Travel
  • Ability to travel domestically and internationally as needed

Rho