Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Clinical Research Associate I (Clinical Trial Or Medical Field Experience Required)

0-2 years
Not Disclosed
10 Dec. 9, 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

Clinical Research Associate I (Remote, NC) | Clinical Trial / Medical Field Experience Required

Location: North Carolina, USA (Remote)
Job ID: 25103725
Updated: December 4, 2025

Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, driving clinical innovation and accelerating the delivery of therapies worldwide. Our Clinical Research Associates (CRA) ensure the integrity of clinical trials while safeguarding participant safety and regulatory compliance.

We are seeking a Clinical Research Associate I (CRA I) with clinical trial or medical field experience to join our remote team in North Carolina. This role is ideal for professionals committed to advancing clinical research excellence while collaborating with diverse stakeholders across global trials.


Key Responsibilities

  • Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (remote or on-site) to ensure regulatory, ICH-GCP, GPP, and protocol compliance.

  • Evaluate site and staff performance, escalate issues, and develop actionable plans in coordination with project teams.

  • Verify informed consent processes and maintain strict subject/patient confidentiality.

  • Review source documents and medical records; ensure data entered in case report forms (CRFs) is accurate and complete.

  • Apply query resolution techniques, providing guidance to site staff for timely closure.

  • Verify investigational product (IP) handling, inventory, dispensing, and adherence to protocol.

  • Maintain Investigator Site File (ISF) and Trial Master File (TMF) alignment, ensuring document accuracy and regulatory compliance.

  • Support participant recruitment, retention, and study awareness initiatives.

  • Manage site-level communications, timelines, and deliverables in alignment with project objectives.

  • Act as liaison with project site personnel and collaborate with Central Monitoring Associates (CMAs) or other CRAs as required.

  • Attend Investigator Meetings, sponsor meetings, and project training sessions.

  • Support audit readiness and preparation, including follow-up actions.

  • For Real World Late Phase studies: provide site support throughout the study lifecycle, conduct chart abstraction, and collaborate with sponsors and local affiliates.


Required Qualifications

  • Bachelor’s degree or RN in a related field (or equivalent education/training/experience).

  • Clinical trial or medical field experience required.

  • Solid knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory standards.

  • Proficiency with computers, clinical software, and willingness to adopt new technologies.

  • Excellent communication, presentation, and interpersonal skills.

  • Ability to manage extensive travel up to 75% as required.

  • US-based candidates only; must comply with site access requirements for medical and personal information.


Why Join Syneos Health

  • Contribute to the success of global clinical trials and innovative therapy development.

  • Work with a dynamic, supportive, and internationally connected clinical research team.

  • Access comprehensive professional development, technical training, and career advancement opportunities.

  • Enjoy competitive benefits, including medical, dental, vision, 401(k) match, Employee Stock Purchase Plan, PTO, and performance-based incentives.

  • Thrive in a culture that values diversity, inclusion, and employee well-being.


About Syneos Health

  • Partnered in the development of 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past five years.

  • Managed over 200 clinical studies across 73,000 sites with more than 675,000 trial participants.

  • Committed to global clinical excellence, innovation, and regulatory compliance.


Summary:
The Clinical Research Associate I is an entry-to-mid level position responsible for monitoring clinical trials, ensuring regulatory and protocol compliance, and supporting site teams throughout the study lifecycle. Ideal candidates possess clinical trial experience, strong regulatory knowledge, and excellent communication skills.

Apply today to join a leading global clinical research organization and make a meaningful impact on the development of life-changing therapies.