Sr Cra - Milano O Roma Home Based

2+ years

Not Disclosed

Remote - Europe

10 Sept. 25, 2024

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Clinical Research Associate (CRA)
Location: Milan or Rome

Company Overview:
Syneos Health® is a premier integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage clinical, medical affairs, and commercial insights to meet the complexities of today's market.

Our Clinical Development model places customers and patients at the forefront of our operations. We strive to simplify and enhance our processes to make Syneos Health not only easy to work with but also a great place to work.

Join a team of passionate problem solvers committed to innovating and helping our clients achieve their goals. With 29,000 employees across 110 countries, we believe that WORK HERE MATTERS EVERYWHERE.

Why Syneos Health?
We are dedicated to the growth of our people through career development, supportive management, and comprehensive training. Our "Total Self" culture allows you to be your authentic self, fostering an environment where everyone feels they belong.

Key Responsibilities:

Conduct site qualifications, initiations, monitoring, and close-out visits (both on-site and remotely) to ensure compliance with regulatory, ICH-GCP, and protocol standards.
Evaluate site performance and provide actionable recommendations, escalating significant issues as necessary.
Verify that informed consent processes are conducted and documented properly, ensuring patient confidentiality and safety.
Conduct assessments of site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP), including Source Document Review and verification of data accuracy in case report forms (CRFs).
Resolve queries and issues promptly while providing guidance to site staff.
Oversee investigational product (IP) inventory and ensure adherence to protocol in dispensing and administration.
Review the Investigator Site File (ISF) for completeness and accuracy, ensuring compliance with documentation requirements.
Document activities through monitoring reports, communication logs, and other necessary project documents.
Understand project scope, timelines, and budgets, managing site-level communication to achieve objectives effectively.
Serve as the primary liaison with site personnel, ensuring all team members are trained and compliant.
Attend and participate in Investigator Meetings and global clinical monitoring/project staff meetings.
Ensure readiness for audits and assist in preparation and follow-up actions.
Mentor junior CRAs and assist with their training and development.

Additional Responsibilities for Real World Late Phase (RWLP):

Support sites throughout the study lifecycle, from identification to close-out.
Collaborate with internal and external stakeholders to gather and communicate regulatory updates and operational efficiencies.
Participate in bid defense meetings and provide insights on local treatment patterns and potential sites.

Qualifications:

Bachelor’s degree or RN in a related field, or an equivalent combination of education and experience.
Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements.
Proficient in computer skills with a willingness to embrace new technologies.
Strong communication, presentation, and interpersonal skills, with a basic level of critical thinking ability.
Willingness to travel up to 75% of the time.

Get to Know Syneos Health:
In the past five years, we have collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, contributing to over 200 studies across 73,000 sites and 675,000+ trial patients.

Additional Information:
This job description is not exhaustive. Responsibilities may be adjusted as needed. The company reserves the right to assign other tasks or duties as necessary. Equivalent experience and qualifications may also be considered.

Syneos Health is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations to assist employees and applicants in performing essential job functions.

If you’re interested in this opportunity but unsure about meeting all qualifications, we encourage you to apply. You might be exactly what we’re looking for!

Explore more about the benefits of working at Syneos Health here.

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Sr Cra - Milano O Roma Home Based

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