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

About Syneos Health:

Syneos Health® is a leading global biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical, and commercial insights into impactful outcomes. We are dedicated to simplifying and streamlining the clinical development process to make it easier for our customers and employees. Our Clinical Development model places both customers and patients at the center of everything we do. We foster a collaborative, innovative, and agile environment to help deliver life-changing therapies faster.

Discover why Syneos Health is a company where working matters everywhere.

Position Overview:

We are seeking a Clinical Research Associate II (CRA II) to join our team in Belgium. In this role, you will be responsible for managing clinical trial sites from start-up through to close-out. You will ensure compliance with regulatory requirements, ICH-GCP guidelines, and study protocols, while supporting sites in delivering high-quality data. As a CRA II, you will perform site qualifications, monitor trial progress, manage site performance, and contribute to the overall success of clinical studies.

Key Responsibilities:

Site Management:
Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely). Evaluate site performance and escalate any serious issues to the project team, developing corrective action plans as needed.
Regulatory Compliance:
Ensure informed consent is obtained appropriately, protecting patient confidentiality, and monitor for protocol deviations and pharmacovigilance issues that may impact patient safety or data integrity.
Clinical Monitoring:
- Assess site processes and review source documents and medical records.
- Verify clinical data entered in the case report form (CRF) is accurate and complete.
- Resolve queries remotely or on-site, guiding site staff to ensure timely query resolution.
Investigational Product (IP) Management:
Oversee IP inventory, reconciliation, and storage. Ensure IP is dispensed and administered per the protocol and verify compliance with GCP and local regulations related to blinded or randomized information.
Documentation & Tracking:
Review and reconcile Investigator Site File (ISF) contents with the Trial Master File (TMF). Ensure essential documents are archived in compliance with local regulations. Document activities such as trip reports, follow-up letters, and communication logs.
Project Coordination:
Ensure project deliverables and timelines are met for site-level activities, adjusting to changes in priorities as necessary. Provide proactive communication to manage site expectations and deliverables.
Training & Mentorship:
Ensure sites and team members are trained on protocol requirements. Mentor junior CRAs and assist in the development of new team members.
Audit Readiness:
Prepare for site audits and ensure sites maintain audit-ready standards. Support preparation for audits and follow-up actions as required.
Travel Requirements:
This position requires up to 50% travel across Belgium to visit clinical trial sites.

Qualifications:

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

Why Syneos Health?

At Syneos Health, we are passionate about career development and progression. We offer supportive management, technical training, mentorship opportunities, and a Total Self culture that encourages you to bring your authentic self to work. We value diversity and inclusion, and we believe that together, we can create a workplace where everyone feels they belong.

Career Growth: Opportunities for professional development and internal promotions.
Diversity & Inclusion: A global culture where diverse perspectives are valued.
Impact: Work with a company that plays a crucial role in the development of therapies that improve patient lives.

Additional Information:

The tasks and responsibilities in this job description are not exhaustive. The company may assign additional tasks and duties as required. Syneos Health is committed to equal employment opportunities and complies with local regulations, including those related to the Americans with Disabilities Act and the EU Equality Directive.

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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

About Syneos Health:

Position Overview:

Key Responsibilities:

Qualifications:

Why Syneos Health?

Additional Information:

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