Sr Cra I Barcelona Or Madrid. Sponsor Dedicated.

Syneos Health

2+ years

Not Disclosed

Remote, USA

10 Nov. 5, 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

Senior Clinical Research Associate I

Company: Syneos Health®
Location: [Location specifics not mentioned]
Job Type: Full-Time

About Syneos Health:

Syneos Health® is a global leader in biopharmaceutical solutions, accelerating the success of our clients through a fully integrated approach. We leverage our expertise in clinical, medical affairs, and commercial insights to deliver real-world outcomes. Our culture of agility, innovation, and customer success allows us to meet modern market demands, drive clinical research forward, and help improve patient lives. With over 29,000 employees across 110 countries, we work together to create a place where people feel empowered to make a difference.

Why Syneos Health:

At Syneos Health, we are committed to developing our people, offering career progression, training, peer recognition, and a total rewards program. Our Total Self culture empowers employees to be their authentic selves and fosters an inclusive environment. We continuously build the company we all want to work for—one that embraces diversity and creates a sense of belonging for everyone.

Job Responsibilities:

As a Senior Clinical Research Associate I, you will be responsible for overseeing the entire clinical trial process, from site qualification to close-out. You will ensure regulatory, ICH-GCP, and protocol compliance while monitoring study sites. Your role will also involve:

Site Management & Monitoring: Perform site qualification, initiation, interim monitoring, and close-out visits (both onsite and remotely). Assess site performance and provide recommendations.
Informed Consent & Patient Safety: Ensure informed consent is obtained and documented for each subject/patient. Protect patient confidentiality and ensure the safety of subjects/patients.
Clinical Data Management: Conduct source document reviews, verify clinical data accuracy and completeness, and resolve queries with site staff.
Investigational Product (IP) Management: Perform inventory, reconciliation, and verify IP storage and dispensation in line with protocol. Ensure compliance with GCP/local regulations.
Document Management: Review the Investigator Site File (ISF) for accuracy and ensure compliance with Trial Master File (TMF) requirements.
Project Tracking: Track activities, observations, and status updates to ensure project timelines and deliverables are met.
Audit Preparation: Support audit readiness and assist with audit preparation and follow-up actions.
Mentorship: Mentor junior CRAs and provide training, as needed. You may also act as the clinical operations lead under supervision.
Real World Late Phase (RWLP): Participate in real-world late-phase studies, including chart abstraction, data collection, and regulatory compliance. Assist with the preparation of informed consent forms and regulatory updates.
Collaboration & Communication: Engage with sponsor representatives, site personnel, and project teams to maintain effective communication and achieve study goals.
Travel Requirements: Up to 75% travel required for site visits and meetings.

Qualifications:

We are looking for candidates who meet the following qualifications:

Educational Requirements: Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
Experience: Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements. At least 3 years of experience in clinical research preferred.
Skills & Competencies:
- Proficiency in computer skills and embracing new technologies.
- Excellent communication, interpersonal, and presentation skills.
- Strong critical thinking and problem-solving abilities.
Other: Ability to manage extensive travel requirements (up to 75%).

Get to Know Syneos Health:

With over 94% of novel FDA-approved drugs and 95% of EMA-authorized products involved in our studies, Syneos Health is making an impact on global healthcare. In addition to supporting therapeutic advancements, we pride ourselves on fostering an environment of innovation, diversity, and inclusion.

Additional Information:

Tasks, duties, and responsibilities in this job description are not exhaustive and may change as per company needs. Syneos Health may also offer reasonable accommodations to employees and applicants with disabilities to assist them in performing essential job functions.

Ready to Apply?
If you're passionate about clinical research and want to be part of a forward-thinking team, we encourage you to apply for this exciting opportunity at Syneos Health.

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