Cra Ii In Neurology - Sponsor Dedicated - Paris Area

2+ years

Not Disclosed

Remote, USA

10 Nov. 5, 2024

Job Description

Job Type: Full Time 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

Job Title: Clinical Research Associate II in Neurology - Sponsor Dedicated - Home Based (Paris Area)
Company: Syneos Health
Location: Home Based (Paris Area)

About Syneos Health

Syneos Health® is a leading biopharmaceutical solutions organization that accelerates customer success through a unique integration of clinical, medical affairs, and commercial expertise. We put the patient and customer at the center of everything we do, simplifying and streamlining processes to make working with us easier—and to make us a better place to work.

With over 29,000 employees across 110 countries, we are passionate about accelerating the delivery of therapies and creating innovative solutions that improve lives.

Why Syneos Health?

At Syneos Health, we are passionate about developing our people. We prioritize career development and progression through:

Engaged line management, technical training, and therapeutic area knowledge
Peer recognition and a robust Total Rewards program
A commitment to our Total Self culture, where you can authentically be yourself and thrive in an inclusive environment

We believe that diversity drives innovation, and we strive to create a workplace where every individual feels they belong.

Position Overview

We are currently seeking a Clinical Research Associate II (CRA II) in Neurology to join our Sponsor Dedicated team, based remotely in the Paris area. In this role, you will be responsible for performing site qualification, initiation, interim monitoring, and close-out visits, ensuring compliance with regulatory standards, ICH-GCP, and protocol requirements. You will collaborate with investigators, study coordinators, and other site personnel to ensure the success of clinical trials in the neurology therapeutic area.

Key Responsibilities

Site Management & Monitoring

Perform site qualification, initiation, interim monitoring, and close-out visits (both onsite and remotely) to ensure regulatory, ICH-GCP, and protocol compliance.
Evaluate site performance and site staff, providing guidance and recommendations to address performance issues and escalating serious concerns as needed.
Ensure that informed consent is properly obtained and documented, maintaining confidentiality and assessing any safety risks or data integrity concerns.
Conduct Source Document Review (SDR) and Source Data Verification (SDV) to ensure accuracy and completeness of clinical data entered into the Case Report Forms (CRFs).
Apply query resolution techniques, providing support to site staff and driving the closure of queries within agreed timelines.

Investigational Product (IP) Management

Perform IP inventory, reconciliation, and ensure proper storage, security, and dispensing of the investigational product according to protocol.
Monitor compliance with local regulations regarding IP labeling, importation, and release/return.

Site Documentation & Tracking

Routinely review the Investigator Site File (ISF) for accuracy, completeness, and timeliness, ensuring alignment with the Trial Master File (TMF).
Ensure that all required study documentation is archived and stored according to local regulations.
Document all activities in line with SOPs and Clinical Monitoring Plans, including trip reports, follow-up letters, communication logs, and more.

Project & Site-Level Support

Understand project scope, budgets, and timelines, managing site-level activities to meet project objectives and deliverables.
Act as the primary liaison with site personnel, ensuring training and compliance with study protocols and regulatory requirements.
Support subject recruitment, retention, and awareness strategies to meet enrollment targets.

Audit Readiness & Compliance

Ensure site readiness for audits by maintaining high standards of documentation and compliance with study procedures.
Participate in Investigator Meetings, sponsor meetings, and global project staff meetings, providing input on study progress and any emerging challenges.

Real-World Late Phase Studies (if applicable)

In the context of Real World Late Phase studies, the CRA II may also serve as a Site Management Associate II, with additional responsibilities, including:
- Providing site support throughout the study lifecycle, from site identification through close-out
- Performing chart abstraction and data collection
- Collaborating with Sponsor affiliates, medical science liaisons, and local staff
- Assisting with the training of junior staff
- Identifying and communicating out-of-scope activities to the Lead CRA or Project Manager

Qualifications

Education & Experience

Bachelor’s degree or RN in a related field (Life Sciences, Nursing, etc.) or an equivalent combination of education, training, and experience.
Minimum of 12 months of experience as a Clinical Research Associate, with demonstrated experience in site monitoring and management.

Technical Skills & Competencies

Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and local regulatory requirements.
Proficiency in using clinical trial management systems (e.g., CTMS) and other software for data capture and study management.
Familiarity with electronic data capture (EDC) systems and ability to ensure site compliance.

Behavioral Competencies

Excellent communication, interpersonal, and presentation skills.
Ability to manage travel requirements (up to 75%).
Highly organized with the ability to adapt to changing priorities and deliver on project timelines.

Why Join Syneos Health?

At Syneos Health, we work with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and have supported over 200 studies across more than 73,000 sites. We are passionate about challenging the status quo and creating innovative solutions to help deliver therapies that change lives.

Join us at Syneos Health and make an impact on the future of clinical research.

Syneos Health is an Equal Opportunity Employer
We are committed to creating a workplace free of discrimination and harassment, and we offer reasonable accommodations to applicants with disabilities when appropriate.