Cra Bulgaria

2+ years

Not Disclosed

Remote - Europe

10 Aug. 20, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

Senior Clinical Research Associate I at Syneos Health

Syneos Health® is a premier, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We merge clinical, medical affairs, and commercial insights to address contemporary market realities and focus on simplifying our processes to enhance both our client and employee experiences.

Why Syneos Health?

Career Development: We invest in our people through continuous career progression opportunities, supportive management, technical training, peer recognition, and a comprehensive rewards program.
Total Self Culture: We foster an inclusive environment where everyone can be their authentic selves. Our Total Self culture connects us globally and is central to our mission.
Innovation and Inclusion: We value diversity of thought, backgrounds, and perspectives, creating a workplace where everyone feels they belong.

Role Overview:

As a Senior Clinical Research Associate I (CRA I) at Syneos Health, you will play a key role in managing clinical trial sites, ensuring compliance with regulatory and protocol standards, and contributing to the success of clinical research projects.

Key Responsibilities:

Site Management: Perform site qualification, initiation, interim monitoring, management, and close-out visits, both on-site and remotely. Ensure compliance with regulatory, ICH-GCP, and protocol standards. Evaluate site performance and address any issues with the project team.
Data Integrity: Verify informed consent processes, protect subject confidentiality, and assess factors affecting subject safety and data integrity. Conduct Source Document Reviews and ensure data accuracy in case report forms.
Inventory and Documentation: Manage investigational product inventory and compliance with protocol. Maintain accurate Investigator Site Files (ISF) and reconcile with the Trial Master File (TMF). Document activities according to SOPs and Clinical Monitoring/Site Management Plans.
Site Support: Assist with recruitment, retention strategies, and maintaining awareness of the study. Act as a primary liaison with project site personnel, and support audit preparation and follow-up actions.
Additional Responsibilities: In Real World Late Phase (RWLP) studies, support site lifecycle activities, collaborate with local and sponsor teams, and suggest operational improvements.

Qualifications:

Education: Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Experience: Strong knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements. Demonstrated computer skills and the ability to adapt to new technologies.
Skills: Excellent communication, presentation, and interpersonal skills. Ability to manage up to 75% travel and demonstrate basic critical thinking skills.

Additional Information:

The responsibilities listed are not exhaustive and may be adjusted as needed. Syneos Health values diverse experiences and is committed to providing reasonable accommodations to support employees in performing their job functions. The company may also offer other tasks or duties as needed and will consider equivalent qualifications.

Apply Now

If you're ready to make an impact and join a dynamic team, apply today or join our Talent Network for future opportunities.

About Syneos Health:

With over 29,000 employees across 110 countries, Syneos Health collaborates on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products. We’re committed to changing lives through innovation and are driven by a passion to deliver meaningful therapies.

Diversity and Inclusion:

We are committed to building a diverse and authentic workplace. If your experience doesn’t align perfectly with the role, we encourage you to apply anyway. Your transferrable skills might be just what we need. Join our Talent Network to stay connected to other career opportunities.

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