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Sr Cra I Seville. Experience In Neurology. Sponsor Dedicated

2+ years
Not Disclosed
10 Nov. 20, 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
Location: Home-Based

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform unique clinical, medical affairs, and commercial insights into outcomes that tackle the challenges of today’s evolving healthcare landscape.

Our Clinical Development model places the customer and the patient at the center of everything we do. We’re constantly looking for ways to streamline processes and make Syneos Health an easier partner to work with—and a better place to work. Whether you're joining us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate professionals, working together to innovate and accelerate the delivery of therapies that change lives.

Why Syneos Health?

We are committed to developing our people through career growth, supportive management, technical and therapeutic area training, and peer recognition. Our Total Self culture encourages authenticity and fosters an inclusive environment where diverse thoughts, backgrounds, and perspectives unite us. We’re building the company we all want to work for—where everyone feels they belong.

Job Responsibilities:

  • Site Management & Monitoring: Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely), ensuring compliance with regulatory standards, ICH-GCP, GPP, and protocol. Use experience and judgment to assess site performance, escalate issues, and develop action plans.

  • Informed Consent & Patient Safety: Ensure informed consent is obtained properly and documented as required. Safeguard patient confidentiality and assess factors that could affect patient safety, data integrity, or protocol adherence.

  • Data Review & Compliance: Perform Source Document Reviews, verify clinical data accuracy in case report forms (CRFs), and resolve data queries in a timely manner. Ensure site compliance with data capture and reporting requirements.

  • Investigational Product (IP) Management: Oversee IP inventory, security, and dispensation. Ensure proper labeling, handling, and storage of investigational products, and verify compliance with blinded or randomized information.

  • Documentation & Reporting: Maintain accurate and timely documentation, including confirmation letters, trip reports, and communication logs, in compliance with SOPs. Track project observations, actions, and outcomes to resolution.

  • Project Coordination: Manage site-level communication, track project timelines, and ensure the achievement of project objectives. Adjust to changing priorities as required.

  • Liaison & Training: Serve as the primary liaison for site personnel, ensuring training and compliance with project requirements. Prepare for and attend Investigator Meetings, sponsor face-to-face meetings, and clinical training sessions.

  • Audit Readiness & Compliance: Help sites meet audit standards and assist in preparing for audits, including follow-up actions.

  • Mentorship & Leadership: Provide training and mentorship to junior CRAs and may lead site visits and sign-offs for more junior staff. Under supervision, may take on clinical operations lead tasks.

  • Real World Late Phase (RWLP) Responsibilities: Support sites throughout the study lifecycle from identification to close-out. Collaborate with affiliates, medical science liaisons, and local staff to manage chart abstraction and data collection. Contribute to process improvements and communicate out-of-scope activities.

    Additional responsibilities in RWLP include:

    • Ensuring local regulatory information is applied and shared
    • Developing country-specific informed consent forms
    • Participating in bid defense meetings

Qualifications:

  • Education: Bachelor’s degree or RN in a related field or equivalent combination of education and experience.
  • Experience: Proven experience as a Clinical Research Associate with knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
  • Skills: Strong computer skills, adaptability to new technologies, and effective communication skills. Basic critical thinking skills are required.
  • Travel: Ability to manage up to 75% travel regularly.

Get to Know Syneos Health

Over the past five years, Syneos Health has worked with 94% of all Novel FDA-Approved Drugs and 95% of EMA Authorized Products. We've collaborated on over 200 studies across 73,000 sites and engaged over 675,000 trial patients.

Join us at Syneos Health and help us challenge the status quo in a dynamic, fast-paced environment where your contributions can make a meaningful impact on global healthcare.