Experienced Cra Denmark

2+ years

Not Disclosed

Remote, USA

10 Nov. 8, 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

Location: Denmark
Company: Syneos Health
Travel: Regular travel within Denmark, occasionally in the wider Nordics region

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We specialize in translating unique clinical, medical, and commercial insights into outcomes that address modern market challenges.

Our Clinical Development model places both the customer and the patient at the heart of everything we do. We continuously work to streamline and simplify our processes, ensuring Syneos Health is not only easier to collaborate with but also an incredible place to work.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate, innovative problem solvers to help customers achieve their goals. We're agile and driven to accelerate therapy delivery because we are committed to changing lives.

Join Syneos Health and discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

Why Syneos Health?

At Syneos Health, we are dedicated to the career development and progression of our people. We offer a supportive and engaged work environment, with access to technical training, therapeutic area expertise, and a comprehensive total rewards program.

We believe in our Total Self culture, where you can authentically be yourself. This inclusive environment is what unites us globally, and it's how we create a place where everyone feels they belong.

Job Responsibilities

As a Clinical Research Associate (CRA) in Denmark, you will be responsible for overseeing clinical trials from start to finish. Your role will include ensuring regulatory compliance, monitoring site activities, and supporting project goals to drive the successful completion of studies.

Site Management & Monitoring:
Perform site qualification, initiation, interim monitoring, and close-out visits (both on-site and remotely). Ensure compliance with regulatory, ICH-GCP, and protocol standards.
Use judgment to evaluate site performance, escalate issues when necessary, and work with site staff to develop corrective action plans.
Informed Consent & Patient Safety:
Ensure proper documentation of informed consent and monitor patient safety throughout the clinical trial. Identify potential risks and address any issues related to protocol deviations, pharmacovigilance, or data integrity.
Data Review & Compliance:
Review and verify data accuracy through source document review and ensure proper electronic data capture at the sites.
Provide guidance to site staff on resolving queries and drive resolution within agreed timelines.
Investigational Product (IP) Management:
Monitor IP inventory, reconciliation, and storage. Ensure proper dispensing, administration, and management of investigational products according to protocol.
Documentation & Reporting:
Regularly update and maintain Investigator Site Files (ISF) and ensure the Trial Master File (TMF) is aligned. Document site activities through letters, reports, and logs as required by the Clinical Monitoring Plan (CMP).
Audit Readiness & Compliance:
Prepare for audits and ensure audit readiness. Support the preparation for audits and address any follow-up actions as needed.
Team Collaboration & Training:
Act as the main liaison between the study team and site personnel. Ensure that all sites are adequately trained and compliant with study requirements.
Provide mentorship and training to junior CRAs.
Project Coordination:
Understand the scope, budgets, and timelines for the clinical study. Ensure the timely completion of site activities and resolution of any issues.
Investigator & Sponsor Meetings:
Prepare for and attend Investigator Meetings and Sponsor face-to-face meetings. Participate in global clinical monitoring/project staff meetings and clinical training sessions.

Qualifications

Education:
Bachelor's degree or RN in a related field, or equivalent combination of education, training, and experience.
Experience:
- Minimum 2-3 years of Clinical Research Associate experience, with previous monitoring experience in Denmark.
- Strong understanding of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
- Prior experience with clinical trials in Immunology, Rare Disease, or related therapeutic areas is a plus.
Skills:
- Excellent communication, presentation, and interpersonal skills.
- Strong attention to detail and critical thinking skills.
- Must be proficient with clinical trial management systems and able to embrace new technologies.
- Fluent in Danish and English.
Travel Requirements:
Regular travel throughout Denmark, with occasional travel in the Nordics region.

Get to Know Syneos Health

In the past five years, Syneos Health has contributed to 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites, reaching over 675,000 trial patients.

Regardless of your role, you’ll have the opportunity to challenge the status quo and make an impact in a dynamic, fast-paced environment. Learn more about Syneos Health and how we’re accelerating therapies that change lives.