Sponsor Dedicated Cra Ii - Uk And Ireland Sites (Can Be Based Anywhere In Uk Or Ireland)

2+ years

Not Disclosed

Remote, USA

10 Nov. 11, 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

Job Title: Clinical Research Associate II

Location: Belgium
Company: Syneos Health

Company Overview:

Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We specialize in translating clinical, medical, and commercial insights into actionable outcomes. We focus on simplifying the clinical development process and putting patients and customers at the center of everything we do. By fostering collaboration and innovation, we are driven to deliver life-changing therapies and accelerate time-to-market.

Position Overview:

Syneos Health is currently seeking a Clinical Research Associate II (CRA II) to join our team in Belgium. The CRA II will perform a variety of site management responsibilities for clinical trials, including site qualification, initiation, monitoring, and close-out visits. This role involves ensuring compliance with regulatory requirements, ICH-GCP guidelines, and study protocols while supporting site staff and managing trial progress. The CRA II will also be responsible for managing site-specific issues, providing guidance, and contributing to the overall success of clinical studies.

Key Responsibilities:

Site Management & Monitoring:
Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (either on-site or remotely). Assess site performance and escalate issues as needed. Ensure regulatory and protocol compliance, and collaborate with the project team to develop action plans for resolution.
Regulatory & Protocol Compliance:
Ensure proper informed consent processes are followed, ensuring confidentiality and patient safety. Monitor for protocol deviations and pharmacovigilance issues, taking appropriate action to address concerns and maintain clinical data integrity.
Data Review & Source Documentation:
Perform Source Document Review (SDR) and Source Data Verification (SDV) to verify that data entered in the case report form (CRF) is accurate and complete. Resolve queries remotely or on-site and guide site staff through resolution to meet agreed timelines.
Investigational Product (IP) Management:
Oversee investigational product (IP) inventory, reconciliation, storage, and security. Ensure that IP is dispensed and administered according to protocol and resolve any issues related to blinded or randomized IP. Ensure proper labeling, importation, and return processes are followed.
Investigator Site File (ISF) Management:
Review the Investigator Site File (ISF) for completeness, accuracy, and timeliness, and ensure it is aligned with the Trial Master File (TMF). Ensure sites are aware of archiving requirements and that essential documents are maintained according to local guidelines and regulations.
Project Coordination:
Manage site-level activities to ensure study milestones, timelines, and deliverables are met. Adapt to changing priorities to achieve study goals and provide proactive communication with internal teams and site personnel.
Training & Mentorship:
Provide site-level training to ensure compliance with study protocols and regulatory requirements. Mentor junior CRAs and assist in the development and training of new site staff.
Audit Readiness & Compliance:
Ensure sites are prepared for audits by maintaining documentation and supporting audit preparation. Guide sites toward maintaining audit-ready standards throughout the study lifecycle.
Travel:
Travel up to 50% of the time to visit sites across Belgium and attend Investigator Meetings and Sponsor meetings as required.

Qualifications:

Education:
Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Experience:
- 2+ years of clinical monitoring experience in a CRO or pharmaceutical environment, including experience in site visits (SIV through to close-out).
- Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
- Proficiency with clinical data management systems and willingness to embrace new technologies.
Skills & Competencies:
- Excellent communication, presentation, and interpersonal skills.
- Strong organizational skills and attention to detail.
- Ability to travel up to 50% of the time for monitoring visits.
- Fluency in Dutch, French, and English.

Why Syneos Health?

Syneos Health is committed to developing our people through career progression, technical training, peer recognition, and a comprehensive rewards program. Our Total Self culture fosters an inclusive environment where you can bring your authentic self to work. We value diverse perspectives and are passionate about changing lives through innovative therapies.

Career Development: Opportunities for career progression, mentorship, and training in a dynamic environment.
Inclusive Culture: We support our employees' well-being and foster an environment where everyone belongs.
Global Reach: Work with a global team and gain exposure to cutting-edge clinical trials and innovative drug development.

Additional Information:

Tasks, duties, and responsibilities outlined in this job description are not exhaustive. The company may assign additional tasks at its discretion. The company is committed to compliance with the Americans with Disabilities Act and local legislation related to equal employment opportunities. Reasonable accommodations will be provided as necessary to assist employees or applicants in performing essential job functions.

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Sponsor Dedicated Cra Ii - Uk And Ireland Sites (Can Be Based Anywhere In Uk Or Ireland)

Job Description

Job Title: Clinical Research Associate II

Company Overview:

Position Overview:

Key Responsibilities:

Qualifications:

Why Syneos Health?

Additional Information:

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