Cra Ii - Must Have Oncology Expereince - Sponsor Dedicated - Bulgaria (Homebased)

2+ years

Not Disclosed

Bulgaria Remote

10 Nov. 26, 2024

Job Description

Job Type: Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Position: Clinical Research Associate II (CRA II)

Company: Syneos Health
Location: Global (with travel up to 75%)

About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization, dedicated to advancing therapies and improving lives. With a collaborative approach, we place customers and patients at the center of everything we do, ensuring innovation and streamlined processes for clinical development.

Responsibilities

As a CRA II, you will ensure regulatory compliance, data integrity, and site performance through effective monitoring and management of clinical trials.

Site Management & Monitoring:

Conduct qualification, initiation, monitoring, and close-out visits (on-site or remote).
Assess site compliance with ICH-GCP, protocol, and regulatory requirements.
Address protocol deviations, pharmacovigilance concerns, and site performance issues.

Data Verification & Documentation:

Review informed consent processes to protect subject confidentiality and safety.
Perform Source Document Reviews (SDR) and ensure data accuracy in CRFs.
Document findings through confirmation letters, follow-up reports, and trip summaries.

Investigational Product (IP) Oversight:

Verify storage, reconciliation, and dispensing of IPs align with protocol and GCP requirements.
Ensure compliance with labeling, import/export, and return standards.

Collaboration & Training:

Act as the primary liaison for study sites, sponsor affiliates, and internal teams.
Provide guidance and support for audits and training for site personnel.
Assist with recruitment, retention, and awareness strategies.

Real World Late Phase (RWL) Responsibilities:

Support site activities from identification to close-out.
Conduct chart abstraction and collaborate with local HCPs.
Mentor junior staff and suggest potential sites based on local expertise.

Qualifications

We seek motivated professionals with strong clinical research experience and the ability to thrive in a dynamic, fast-paced environment.

Education & Experience:

Bachelor's degree or RN in a relevant field (or equivalent experience).
Comprehensive knowledge of ICH/GCP guidelines and regulatory frameworks.

Skills:

Proficiency with new technologies and clinical research tools.
Strong communication, presentation, and interpersonal abilities.
Flexibility to travel up to 75% and adapt to shifting priorities.

Why Join Syneos Health?

A Culture of Inclusion:
Our Total Self culture encourages authenticity and values diversity, fostering an environment where everyone belongs.

Opportunities for Growth:

Career progression pathways tailored to your aspirations.
Therapeutic training and exposure to innovative clinical trials.

Global Impact:
Collaborate on transformative projects, including over 200 studies and 94% of novel FDA-approved drugs in the last five years.

Additional Information

This role offers exposure to diverse therapeutic areas, global project teams, and cutting-edge therapies. Syneos Health is committed to creating an inclusive workplace, providing reasonable accommodations to support all employees in achieving their best performance.

Interested?
Be part of a team that accelerates the delivery of life-changing therapies. Explore more at Syneos Health Careers.

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