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Senior Cra

0-2 years
Not Disclosed
10 April 3, 2025
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

 

 


Senior Clinical Research Associate

Company: Syneos Health
Location: Global

About Syneos Health

Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success by combining clinical, medical affairs, and commercial insights. With 29,000 employees across 110 countries, we simplify and streamline clinical development to bring innovative therapies to patients faster.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to deliver impactful results in the biopharma industry.

Join us—because work here matters everywhere.


Job Responsibilities

Clinical Site Management & Monitoring

  • Conduct site qualification, initiation, monitoring, and close-out visits (on-site or remote).

  • Ensure compliance with ICH-GCP, GPP, regulatory guidelines, and protocols.

  • Evaluate site performance and provide recommendations for improvements.

  • Manage investigational product (IP) inventory, storage, and compliance.

  • Verify the process of informed consent and ensure patient confidentiality.

  • Review Investigator Site Files (ISF) for accuracy, completeness, and compliance with Trial Master File (TMF).

Data Collection & Query Resolution

  • Conduct Source Document Review (SDR) and validate case report forms (CRFs).

  • Ensure accurate and timely data entry into electronic data capture (EDC) systems.

  • Identify protocol deviations, pharmacovigilance issues, and patient safety concerns.

  • Apply query resolution techniques and drive resolution within set timelines.

Communication & Training

  • Act as a liaison with site personnel and internal project teams.

  • Provide training and mentorship to junior Clinical Research Associates (CRAs).

  • Participate in Investigator Meetings, project team discussions, and training sessions.

  • Support sites in audit readiness and regulatory inspections.

Operational & Project Management

  • Manage site-level activities to ensure timelines, budgets, and objectives are met.

  • Assist with subject recruitment, retention, and study awareness strategies.

  • Track all observations, status updates, and action items using internal systems.

  • Identify operational efficiencies and process improvements.

Real-World Late Phase (RWLP) Studies

  • Support site identification and data collection in real-world late-phase studies.

  • Ensure compliance with local regulatory requirements.

  • Build relationships with healthcare providers, advocacy groups, and sponsor affiliates.

  • Assist in bid defense meetings and protocol feasibility discussions.


Required Qualifications

  • Education: Bachelor’s degree or RN in a related field.

  • Experience: Equivalent combination of education, training, and experience.

  • Technical Skills:

    • Strong knowledge of Good Clinical Practice (GCP) and ICH guidelines.

    • Proficiency in electronic data capture (EDC) systems.

    • Strong computer skills and ability to adopt new technologies.

  • Soft Skills:

    • Excellent communication, presentation, and interpersonal skills.

    • Strong critical thinking and problem-solving abilities.

  • Travel Requirements:

    • Must be able to manage up to 75% travel as required.


Why Join Syneos Health?

  • 94% of all Novel FDA-Approved Drugs in the past 5 years involved Syneos Health.

  • 95% of EMA-Authorized Products and over 200 studies across 73,000 sites.

  • Work with a diverse, inclusive, and innovative team.

  • Competitive career development, mentorship, and rewards program.

  • Be part of a mission-driven organization changing lives through clinical research.


Join Us

We encourage applicants from diverse backgrounds and industries. If your experience doesn’t align perfectly, apply anyway—your skills may be transferable.

Join our Talent Network to stay updated on career opportunities at Syneos Health.