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Clinical Research Associate Ii / Sr Cra - Full Service - Onc + Gen Med (Home-Based In Eastern Us)

2-4 years
Not Disclosed
10 Sept. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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:

Clinical Research Associate II / Sr CRA – Full Service (ONC + Gen Med, Home-Based – Eastern US)

Company: Syneos Health®
Location: Remote, Eastern US
Job ID: 25101613
Updated: September 22, 2025


About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success. Our Clinical Development model places the patient and customer at the center of everything we do, while continuously improving processes to enhance efficiency and effectiveness.

Key Highlights:

  • 29,000 employees across 110 countries

  • Supported 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products

  • Contributed to 200+ studies across 73,000 sites and 675,000+ trial patients

Culture:

  • Total Self culture – promoting authenticity

  • Career development, technical and therapeutic training, peer recognition, and total rewards

  • Inclusive, diverse workplace fostering belonging


Job Summary

The Clinical Research Associate II / Sr CRA ensures clinical research studies are conducted according to Good Clinical Practice (GCP) and widely accepted clinical standards. The role involves on-site and remote monitoring, development and implementation of monitoring tools, and management of defined project components to maintain high-quality clinical trial operations.


Core Responsibilities

  • Conduct on-site and remote monitoring of clinical trials, reviewing study protocols, informed consent forms, and case report forms (CRFs).

  • Develop and implement monitoring tools, procedures, and processes, including monitoring plans, checklists, and templates.

  • Contribute to the design, implementation, and delivery of processes, programs, and policies; participate in SOP and training material development.

  • Manage defined project components, including site visit coordination, study progress tracking, and issue resolution.

  • Ensure accurate and timely documentation of monitoring activities, including monitoring reports, follow-up letters, and action plans.

  • Collaborate with cross-functional teams, investigators, and site staff to support smooth study conduct.


Qualifications

  • Bachelor’s degree in a related field, or equivalent experience.

  • 2–4 years of experience in clinical research monitoring.

  • Strong knowledge of GCP guidelines and regulatory requirements.

  • Excellent communication, interpersonal, and organizational skills.

  • Ability to work independently and manage multiple priorities.

  • Proficiency in clinical trial management systems and relevant software.

Preferred Certifications:

  • Certified Clinical Research Associate (CCRA) or equivalent.

Necessary Skills:

  • Attention to detail and strong analytical skills

  • Problem-solving and critical thinking

  • Team collaboration and effective communication

  • Strong time management and organizational skills

  • Proficiency in Microsoft Office Suite


Benefits & Compensation

  • Company car or car allowance

  • Health benefits: Medical, Dental, Vision

  • 401(k) with company match

  • Employee Stock Purchase Plan eligibility

  • Commission/bonus opportunities based on company and individual performance

  • Flexible PTO and sick time (subject to state/municipal regulations)

Salary:

  • Base salary range depends on qualifications, skills, and experience.


Summary

Roles at the P21 level in Clinical Monitoring/CRA focus on ensuring clinical trials are conducted in compliance with accepted practices. Responsibilities include monitoring studies, developing monitoring tools and procedures, managing project components, and maintaining high standards of clinical practice. Individuals in this role leverage education and experience to contribute to the design, implementation, and delivery of processes and policies, ensuring study integrity and advancing medical knowledge.

Core Focus:

  • Conduct thorough on-site and remote clinical monitoring

  • Develop and implement quality monitoring tools and processes

  • Manage defined project components and contribute to trial success

  • Maintain high standards of clinical practice and regulatory compliance