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Cra Ii / Sr Cra - Sponsor Dedicated - Oncology + Gen Med (Home-Based In Western Us)

0-2 years
Not Disclosed
10 Oct. 2, 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

๐Ÿงพ Job Title

CRA II / Sr CRA - Sponsor Dedicated - Oncology + General Medicine (Home-Based in Western US)

Updated: September 25, 2025
Location: USA – AZ – Remote
Job ID: 25102049


๐Ÿข About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success.
We combine clinical, medical affairs, and commercial expertise to deliver innovative outcomes for modern healthcare challenges.

With 29,000 employees in 110 countries, we believe:

“Work Here Matters Everywhere.”


๐ŸŒ Why Work with Us

  • ๐Ÿ’ก Career Growth – Continuous career development, training, and advancement opportunities

  • ๐Ÿค Supportive Culture – Engaged line management and peer recognition programs

  • ๐Ÿง˜ Total Self Culture – Be authentically yourself and thrive in an inclusive workplace

  • ๐ŸŒ Diversity & Inclusion – Bringing diverse thoughts and perspectives together to foster belonging


๐ŸŽฏ Job Responsibilities

๐Ÿ”น Monitoring & Compliance

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

  • Ensure ICH-GCP, GPP, and regulatory compliance

  • Evaluate site and staff performance; escalate serious issues and develop corrective action plans

๐Ÿ”น Patient Safety & Data Integrity

  • Verify informed consent process and documentation

  • Protect patient confidentiality

  • Identify protocol deviations/violations and pharmacovigilance issues

๐Ÿ”น Source Data & Documentation

  • Review source documents, CRFs, and medical records

  • Ensure accurate and complete data entry and timely query resolution

  • Manage electronic data capture (EDC) compliance

๐Ÿ”น Investigational Product (IP) Oversight

  • Perform IP inventory, reconciliation, and storage review

  • Verify IP dispensing per protocol

  • Ensure labeling, import/export, and release/return compliance

๐Ÿ”น Site File Management

  • Routinely review Investigator Site File (ISF) for accuracy

  • Reconcile ISF with Trial Master File (TMF)

  • Ensure archiving compliance

๐Ÿ”น Documentation & Communication

  • Prepare confirmation/follow-up letters, trip reports, and communication logs

  • Track observations, status, and action items in project systems

  • Support patient recruitment, retention, and site engagement

๐Ÿ”น Project Management

  • Understand project scope, budget, and timelines

  • Manage site-level deliverables and timely issue resolution

  • Act as primary liaison with site personnel and Central Monitoring Associates

๐Ÿ”น Training & Audit Readiness

  • Ensure site training compliance

  • Participate in Investigator Meetings, Sponsor meetings, and staff training

  • Support audit readiness and follow-up actions


๐Ÿ“˜ Additional Responsibilities (for Real-World Late Phase Studies)

  • Support site lifecycle from identification to close-out

  • Conduct chart abstraction and data collection

  • Collaborate with Sponsor affiliates, MSLs, and local country staff

  • Train junior staff as needed

  • Suggest potential sites based on local treatment insights


๐ŸŽ“ Qualifications

  • Bachelor’s Degree or Registered Nurse (RN) in a related field

  • Strong knowledge of ICH-GCP and regulatory guidelines

  • Proficiency in computer systems and new technologies

  • Excellent communication, presentation, and interpersonal skills

  • Ability to travel up to 75% regularly

๐Ÿฉบ Note (US Only):
Some sites may require medical or personal information for facility access. Compliance is mandatory for continued employment.


๐Ÿ’ฐ Compensation & Benefits

  • Competitive base salary (range varies by qualifications and region)

  • Health, Dental, and Vision insurance

  • 401(k) with company match

  • Stock Purchase Plan eligibility

  • Bonus/Commission opportunities

  • Flexible Paid Time Off (PTO) and Sick Leave

  • Company Car or Car Allowance (where applicable)


๐Ÿง  Summary

Roles within Clinical Monitoring / CRA focus on:

  • Ensuring trial integrity via centralized and on-site monitoring

  • Using data analytics and risk-based monitoring

  • Collaborating with site teams to improve quality and compliance

  • Managing study delivery, data accuracy, and regulatory adherence

This is an individual contributor role requiring practical, hands-on experience and the ability to manage components of projects and processes.


๐ŸŒ About Syneos Health (Quick Facts)

  • Partnered in 94% of FDA Novel Drug Approvals

  • Involved in 95% of EMA Authorized Products

  • Conducted 200+ Studies across 73,000 sites

  • Supported 675,000+ Trial Patients

๐Ÿ”— Learn More: syneoshealth.com


๐Ÿค Equal Opportunity & Compliance

Syneos Health is committed to:

  • Equal Employment Opportunity (EEO)

  • Americans with Disabilities Act (ADA) accommodations

  • Inclusive hiring aligned with EU Equality Directives


๐Ÿ“ฉ Application

Interested?
๐Ÿ‘‰ [Apply Now]
or
๐Ÿ’ผ Join our Talent Network to stay updated on future opportunities.

๐Ÿ’ก If your experience doesn’t align perfectly, apply anyway — transferable skills are valued.