Sr. Cra Ii - Sponsor Dedicated - Oncology - 6+ Years Of Independent Monitoring Experience (Home-Based - Northeast Of Us)

3-5 years

$80,600 – $145,000

Remote, USA

10 Sept. 17, 2025

Job Description

Job Type: Full Time Remote 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

Senior Clinical Research Associate II – Sponsor Dedicated (Oncology)

Location: Home-Based – Northeast USA (Remote)
Job Type: Full-time, Remote
Job ID: 25101844
Updated: September 15, 2025

Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We deliver innovative clinical, medical affairs, and commercial insights to improve patient outcomes. Our teams operate in Functional Service Provider (FSP) partnerships and Full-Service environments, collaborating to streamline clinical development and deliver therapies faster.

Why Join Syneos Health:

Career development and progression opportunities

Supportive and engaged line management

Technical and therapeutic training

Peer recognition and total rewards programs

Total Self culture promoting authenticity, diversity, and inclusion

Role Overview

The Sr. CRA II is responsible for monitoring oncology clinical trials and ensuring compliance with ICH-GCP, protocols, SOPs, and regulatory requirements. This role combines individual contributor responsibilities with functional oversight, including mentoring junior CRAs and acting as a primary liaison with study sites.

Core Responsibilities:

Conduct on-site and remote monitoring of clinical research studies

Verify data accuracy, completeness, and adherence to study protocols

Develop monitoring tools, processes, templates, and checklists

Contribute to study design, protocol development, and methodology input

Manage and direct lower-level professionals or processes

Maintain accurate and timely documentation of site visits, monitoring activities, and reports

Collaborate with cross-functional teams (data management, biostatistics, regulatory affairs)

Identify and resolve clinical trial issues impacting conduct or data integrity

Provide training, mentorship, and guidance to junior CRAs

Ensure audit readiness at site and project level

Detailed Responsibilities

Ensure regulatory, ICH-GCP, and protocol compliance across site qualification, initiation, interim monitoring, management, and close-out

Evaluate site and staff performance; recommend site-specific actions and escalate serious issues

Verify informed consent process and assess factors affecting patient safety and data integrity

Conduct Source Document Review, data verification, and query resolution

Ensure compliance with electronic data capture, investigational product inventory, storage, and security

Review Investigator Site File (ISF) and reconcile with Trial Master File (TMF)

Document site activities through trip reports, confirmation/follow-up letters, and communication logs

Act as primary site liaison and provide guidance on training and audit readiness

Qualifications

Education:

Bachelor’s degree in a related field

Experience:

Minimum 6 years of independent clinical monitoring experience (oncology preferred)

3–5 years in clinical research or related field required

Experience supervising or mentoring junior CRAs preferred

Skills & Knowledge:

Strong knowledge of clinical trial processes and regulations

Proficiency in clinical trial management systems and software

Excellent organizational, analytical, and problem-solving skills

Strong communication and interpersonal skills

Ability to manage multiple projects and priorities independently

Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

Certifications:

Certified Clinical Research Professional (CCRP) or equivalent preferred

Compensation & Benefits

Salary Range: $80,600 – $145,000 (dependent on qualifications, experience, location)

Benefits may include:

Company car or car allowance

Health benefits (Medical, Dental, Vision)

Company match 401(k)

Employee Stock Purchase Plan eligibility

Commissions/bonus based on performance

Flexible paid time off (PTO) and sick time

Impact & Contribution

Ensure clinical trials are conducted, recorded, and reported per protocol and regulatory standards

Contribute to the quality and integrity of clinical data

Protect confidentiality and safety of trial participants

Act as functional lead at site and project levels

Provide guidance and recommendations to sites and project teams

Additional Information

Tasks may evolve based on company discretion

Transferrable skills considered for applicants with relevant experience

Compliance with Americans with Disabilities Act and reasonable accommodations

Learn more: Syneos Health

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Sr. Cra Ii - Sponsor Dedicated - Oncology - 6+ Years Of Independent Monitoring Experience (Home-Based - Northeast Of Us)

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