Sr Cra Ii (Sponsor Dedicated) Greece

2+ years

Not Disclosed

Remote, USA

10 Nov. 6, 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: Senior Clinical Research Associate I
Company: Syneos Health®

About Syneos Health:
Syneos Health is a leading integrated biopharmaceutical solutions organization focused on accelerating customer success. We combine clinical, medical affairs, and commercial expertise to address modern market challenges and improve patient outcomes. Whether you join us in a Functional Service Provider (FSP) partnership or Full-Service model, we collaborate with passionate problem solvers to deliver impactful therapies faster. At Syneos Health, we’re not just making the future of healthcare happen — we’re changing lives in the process.

Why Syneos Health:
At Syneos Health, we are passionate about developing our people, supporting career growth through mentorship, technical and therapeutic area training, and recognition programs. We are committed to a "Total Self" culture that celebrates diversity and inclusivity, creating a workplace where everyone feels they belong. Join us in building the company we want to work for — one that fosters innovation, collaboration, and personal growth.

Job Description:

The Senior Clinical Research Associate I will oversee and manage clinical trial activities, ensuring compliance with regulatory, ICH-GCP, and study protocols. Working both onsite and remotely, you’ll play a critical role in supporting the lifecycle of clinical studies, from site qualification through to close-out visits. This role involves proactive monitoring of site activities, resolution of issues, and ensuring quality clinical data and patient safety throughout the study process.

Key Responsibilities:

Site Management & Monitoring: Perform site qualification, initiation, interim monitoring, and close-out visits. Ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and local regulatory requirements.
Data & Documentation Accuracy: Verify clinical data entered into Case Report Forms (CRFs) is accurate by reviewing source documents and medical records. Ensure Investigator Site Files (ISF) and Trial Master Files (TMF) are accurate and up-to-date.
Patient Safety & Informed Consent: Ensure proper documentation of informed consent processes and patient safety assessments. Escalate any protocol deviations, pharmacovigilance issues, or patient safety concerns.
Site Support & Training: Provide training and support for site staff and ensure compliance with study protocols, timelines, and data entry requirements. Assist with investigator meetings and sponsor face-to-face meetings.
Investigational Product (IP) Management: Ensure the proper handling, labeling, and reconciliation of investigational products, including dispensation, storage, and security according to study protocols.
Query Resolution: Resolve site queries and issues related to clinical data entry, protocol deviations, and regulatory compliance, working with site staff to ensure timely closure.
Audit Readiness: Assist in preparing for audits, ensuring sites are audit-ready and comply with Good Clinical Practice (GCP), study protocols, and regulatory requirements.
Operational Efficiency: Identify opportunities for process improvements and operational efficiencies throughout the study lifecycle, ensuring all site activities align with project goals and timelines.
Late Phase Real-World Studies: Support Real World Late Phase (RWLP) studies by managing site activities, developing informed consent forms, and assisting with chart abstraction and data collection.

Additional Responsibilities:

Collaborate with Sponsor teams and local country staff to ensure all site-specific requirements are met.
Proactively suggest and evaluate potential sites based on local knowledge, treatment patterns, and healthcare provider relationships.
Contribute to bid defense meetings and assist in the selection of sites for upcoming studies.
Support recruitment, retention, and awareness strategies to ensure smooth study progression.

Qualifications:

What we’re looking for:

Education: Bachelor’s degree or Registered Nurse (RN) in a related field, or equivalent combination of education, training, and experience.
Experience: Previous experience as a CRA, with a solid understanding of clinical trial protocols, ICH/GCP guidelines, and regulatory requirements.
Skills: Strong computer skills and ability to quickly adapt to new technologies. Strong communication, presentation, and interpersonal skills, with the ability to think critically and make decisions.
Travel Requirements: Ability to travel up to 75% of the time.
Additional: Knowledge of real-world late-phase study designs and regulatory requirements.

Why Join Syneos Health?
Syneos Health is at the forefront of biopharmaceutical innovation, having supported the development of 94% of all novel FDA-approved drugs and 95% of EMA-authorized products. With over 200 studies across 73,000 sites, we are committed to improving patient outcomes through collaborative partnerships, diverse perspectives, and a shared commitment to clinical excellence.

Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. The company is committed to compliance with all local regulations, including the Americans with Disabilities Act, providing reasonable accommodations when necessary to support employees in performing the essential functions of their role.

Syneos Health is an Equal Opportunity Employer
We embrace diversity and are committed to providing an inclusive and accessible workplace for all candidates. We welcome applications from all qualified individuals without regard to race, religion, gender, age, disability, or any other protected status.

If you’re ready to join a global leader in biopharmaceutical solutions and make a real impact in clinical research, apply today!