Sr Cra - Milano O Roma Home Based

2+ years

Not Disclosed

Remote

10 Oct. 21, 2024

Job Description

Job Type: Full Time 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

Senior Clinical Research Associate - Milan or Rome

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.

Our Clinical Development model places both the customer and the patient at the heart of everything we do. We continually strive to simplify our processes, making Syneos Health easier to work with and for. Whether in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to expedite the delivery of therapies, as we are passionate about changing lives.

Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

Why Syneos Health

We are committed to developing our people through career progression, supportive management, technical training, peer recognition, and a comprehensive rewards program. Our Total Self culture allows you to be your authentic self, uniting us globally and ensuring everyone feels they belong.

Job Responsibilities

Conduct site qualification, initiation, interim monitoring, management, and close-out visits, ensuring compliance with regulatory guidelines, ICH-GCP, and study protocols.
Verify informed consent processes and protect patient confidentiality.
Assess factors affecting patient safety and data integrity at investigator sites, addressing protocol deviations and pharmacovigilance issues.
Conduct Source Document Reviews and ensure accuracy of data entered in case report forms (CRFs).
Drive query resolution through effective communication with site staff.
Verify compliance with electronic data capture requirements and manage investigational product inventory and security.
Maintain accurate Investigator Site Files (ISF) and ensure proper archiving of essential documents.
Document activities through confirmation letters, trip reports, and other required documents.
Support patient recruitment and retention strategies and manage site-level activities to meet project timelines.
Act as a liaison with project site personnel, ensuring training and compliance.
Prepare for and attend Investigator and sponsor meetings, providing guidance on audit readiness.
Train and mentor junior CRAs, and take on clinical operations lead tasks under supervision.
For Real World Late Phase (RWLP) studies, you may work under the title of Senior Site Management Associate I.

Qualifications

What We’re Looking For:

Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
Proficiency in computer skills and a willingness to adopt new technologies.
Excellent communication, presentation, and interpersonal skills, with a basic level of critical thinking.
Ability to manage travel of up to 75% regularly.

Get to Know Syneos Health

In the past five years, we have partnered in the development of 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, conducting over 200 studies across 73,000 sites and 675,000+ trial patients. Join us in taking initiative and challenging the status quo in a highly competitive and evolving environment.

Additional Information:

The tasks, duties, and responsibilities listed in this job description are not exhaustive. The company may assign other tasks and responsibilities at its discretion. Equivalent experience, skills, and education will also be considered. This document does not constitute an employment contract.

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Sr Cra - Milano O Roma Home Based

Job Description

Senior Clinical Research Associate - Milan or Rome

Why Syneos Health

Job Responsibilities

Qualifications

Get to Know Syneos Health

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