Instagram
youtube
Facebook

Senior Cra

0--2 years
Not Disclosed
10 April 1, 2025
Job Description
Job Type: Remote 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 (Senior CRA)

Updated: March 10, 2025
Location: India-Asia Pacific (IND-Home-Based)
Job ID: 24006813
Company: Syneos Health


Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization. With over 29,000 employees across 110 countries, the company focuses on accelerating clinical development, medical affairs, and commercial success. Syneos Health prioritizes customer and patient-centric innovation to streamline processes and enhance outcomes.

Why Join Syneos Health?

  • Career development and training opportunities

  • Supportive and engaged leadership

  • Inclusive workplace culture

  • Competitive benefits and rewards program


Job Responsibilities

The Senior Clinical Research Associate (CRA) will perform various clinical trial monitoring activities to ensure compliance with regulatory guidelines, Good Clinical Practice (GCP), and study protocols. Key responsibilities include:

Site Monitoring & Compliance

  • Conducts site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely).

  • Evaluates site performance and ensures compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and regulatory standards.

  • Assesses site processes and conducts source document reviews to verify clinical data accuracy.

  • Ensures the informed consent process is documented and compliant with ethical guidelines.

  • Identifies and escalates protocol deviations, pharmacovigilance issues, and patient safety concerns.

Data Integrity & Documentation

  • Verifies clinical data accuracy in Case Report Forms (CRFs) via medical record review.

  • Resolves data queries and supports electronic data capture compliance.

  • Reviews and reconciles Investigator Site Files (ISF) with the Trial Master File (TMF).

  • Documents monitoring activities through trip reports, confirmation letters, and follow-up communications.

Investigational Product (IP) Management

  • Conducts IP inventory and reconciliation and ensures proper storage and security.

  • Ensures IP is dispensed and administered correctly per protocol.

  • Ensures compliance with labeling, import, and release regulations.

Project Management & Collaboration

  • Works closely with site personnel, sponsors, and regulatory teams to meet project objectives.

  • Prepares and attends Investigator Meetings and sponsor face-to-face meetings.

  • Supports audit readiness and regulatory inspections.

  • May mentor and train junior CRAs and provide operational leadership.

Real World Late Phase (RWLP) Responsibilities

For RWLP studies, the Senior CRA will also:

  • Support site identification to study close-out.

  • Conduct chart abstraction and data collection.

  • Identify operational efficiencies and site selection opportunities.

  • Develop country-level informed consent forms and ensure compliance with local regulatory requirements.


Qualifications & Requirements

  • Education: Bachelor's degree or RN in a related field, or an equivalent combination of education, training, and experience.

  • Experience & Knowledge:

    • Strong understanding of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.

    • Ability to manage site-level activities and ensure compliance.

  • Technical Skills:

    • Proficient in clinical trial software and electronic data capture systems.

    • Strong documentation and reporting skills.

  • Soft Skills:

    • Excellent communication, presentation, and interpersonal skills.

    • Ability to work in a fast-paced and dynamic environment.

  • Travel Requirements: Up to 75% travel on a regular basis.


How to Apply

Interested candidates can apply here or join the Syneos Health Talent Network for future opportunities.

About Syneos Health

  • Worked on 94% of all Novel FDA Approved Drugs in the past 5 years.

  • Collaborated on 95% of EMA Authorized Products.

  • Conducted 200+ studies across 73,000 sites and 675,000+ trial patients.

At Syneos Health, we value diversity, inclusion, and transferable skills. If your experience doesn’t align perfectly, we encourage you to apply anyway.