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2+ years
Not Disclosed
10 April 25, 2025
Job Description
Job Type: Full Time 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 I
 

Updated: April 23, 2025
Location: Poland-Europe - POL-Home-Based
Job ID: 25003312


Position: Senior Clinical Research Associate I
Company: Syneos Health

About Syneos Health:
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With a strong focus on clinical development, the company ensures the patient and customer remain at the center of every initiative. The organization supports innovative solutions in both Full-Service and Functional Service Provider partnerships, with a team of over 29,000 employees across 110 countries.


Why Join Syneos Health:

  • Career growth through structured development programs.

  • Inclusive, authentic culture under the "Total Self" initiative.

  • Peer recognition and total rewards program.

  • Commitment to diversity and global belonging.


Job Responsibilities:

  • Conduct site qualification, initiation, monitoring, management, and close-out visits, both on-site and remotely.

  • Ensure compliance with regulatory requirements, GCP/ICH guidelines, and protocols.

  • Evaluate site and staff performance, escalating issues when needed.

  • Confirm proper informed consent documentation and safeguard patient confidentiality.

  • Conduct source document review and ensure CRF data accuracy.

  • Apply query resolution strategies and provide site support.

  • Manage investigational product (IP) logistics and compliance.

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

  • Document all visit activities and maintain project tracking systems.

  • Coordinate with project teams to align on scope, budget, and timelines.

  • Act as site liaison and ensure training compliance.

  • Prepare for and participate in Investigator Meetings and sponsor meetings.

  • Provide site-level guidance for audit readiness and assist with follow-ups.

  • Train or mentor junior CRAs as assigned.

  • Support Real World Late Phase (RWLP) projects and assume title Sr. Site Management Associate I where applicable.


Additional RWLP Responsibilities:

  • Engage in site support from identification to close-out.

  • Understand local study requirements and data collection practices.

  • Collaborate with sponsors, affiliates, and regulatory teams.

  • Identify operational efficiencies and suggest site candidates.

  • Participate in bid defense and consent form development.


Qualifications:

  • Bachelor’s degree or RN in a relevant field (or equivalent experience).

  • Solid knowledge of GCP, ICH, and applicable regulations.

  • Proficient computer skills and adaptability to new technologies.

  • Strong interpersonal, presentation, and communication skills.

  • Basic critical thinking and problem-solving capabilities.

  • Willingness to travel up to 75% regularly.


Additional Notes:
Responsibilities outlined are not exhaustive. Equivalent skills, education, and experience may be considered. Syneos Health is committed to equality and providing reasonable accommodations per local legislation, including the Americans with Disabilities Act and EU Equality Directive.