Sr Cra I (Slovakia) - Sponsor-Dedicated

2+ years

Not Disclosed

Remote, USA

10 Nov. 18, 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: Senior Clinical Research Associate I (Slovakia) - Sponsor-Dedicated

Company: Syneos Health®

About Syneos Health: Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. We focus on bringing customers and patients to the center of everything we do, continuously seeking innovative ways to simplify and streamline our work. With over 29,000 employees across 110 countries, we are passionate about changing lives.

Why Syneos Health? We are committed to developing our people through career progression, technical training, and a culture where you can be your authentic self. Our "Total Self" culture fosters diversity, inclusivity, and a supportive environment where everyone feels they belong. We're building a company where people are motivated to excel and drive customer success.

Job Responsibilities: As a Senior Clinical Research Associate I (CRA I), you will be responsible for the following:

Site Management: Perform site qualification, initiation, monitoring, and close-out visits (either on-site or remotely) ensuring compliance with regulatory, ICH-GCP guidelines, and study protocols.
Site Performance Evaluation: Assess site processes and provide recommendations for improvement; escalate issues to the project team as necessary.
Data Verification: Review site source documents and medical records for accuracy and completeness; apply query resolution techniques to ensure data integrity.
Investigational Product (IP) Management: Ensure IP is dispensed and administered correctly according to the study protocol.
Document Management: Maintain and review the Investigator Site File (ISF) and ensure all required documents are accurately archived.
Regulatory Compliance: Ensure all site activities are in line with regulatory requirements and support audit readiness.
Collaboration & Training: Support recruitment, retention, and awareness strategies. Train and mentor junior CRAs, and contribute to project team meetings.
Late Phase Real World Studies: Assist in the design and implementation of late-phase studies, including chart abstraction and data collection.

Qualifications:

Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Solid understanding of Good Clinical Practice (GCP), ICH Guidelines, and other relevant regulations.
Proficiency in using clinical research technologies and software.
Strong communication, presentation, and interpersonal skills.
Ability to manage up to 75% travel for the role.

Additional Responsibilities:

Ensure compliance with local requirements for late-phase study designs.
Build relationships with sponsors, medical science liaisons, and local teams.
Identify and recommend operational efficiencies.
Participate in bid defense meetings and support global monitoring activities.

Company Overview: Syneos Health has been instrumental in the approval of 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites globally. Our diverse team is dedicated to innovation and excellence in clinical development.

Additional Information: The tasks outlined are not exhaustive and the company may assign other duties as necessary. The company may also consider equivalent experience for applicants. Syneos Health is an equal opportunity employer and will provide accommodations as needed under the Americans with Disabilities Act.

Location: Slovakia

Travel Requirement: Up to 75% travel

Job Type: Full-time, Permanent

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Sr Cra I (Slovakia) - Sponsor-Dedicated

Job Description

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