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Clinical Research Associate Ii

1-3 years
Not Disclosed
10 July 19, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Job Opportunity: Site Monitor

Company: ICON plc
Location: India
Type: Full-Time

About ICON:

ICON plc is a world-leading healthcare intelligence and clinical research organization. We advance clinical research from molecule to medicine, offering outsourced services to pharmaceutical, biotechnology, medical device, and government/public health organizations. Our mission is to accelerate the development of drugs and devices that save lives and enhance quality of life. Our success is driven by our people, who are at the heart of our culture and achievements.

Role Overview:

As a Site Monitor at ICON, you will be responsible for overseeing site activities to ensure compliance with clinical trial protocols, regulatory requirements, and good clinical practices. You will manage site interactions and contribute to the overall success of clinical trials.

Key Responsibilities:

  • Site Monitoring: Conduct site visits to monitor clinical trial progress, ensuring adherence to study protocols and regulatory requirements.
  • Site Initiation Visits (SIV) and Close-Out Visits (COV): Perform initiation and close-out visits, including site qualification and final documentation.
  • Principal Investigator (PI) Management: Manage relationships with Principal Investigators and site staff to ensure smooth trial operations.
  • Audit and Inspection: Prepare for and support site audits and inspections, ensuring compliance with all relevant guidelines and regulations.
  • NDCT Rule Compliance: Ensure adherence to the National Drug Code (NDCT) rules and regulations.

Experience Required:

  • Site Monitoring Experience: More than 1.5 years of experience in site monitoring.
  • Education: Pharm D or equivalent degree.
  • Communication Skills: Excellent communication skills are essential.

Why ICON?

  • Competitive Reward Package: We offer a comprehensive reward package, including competitive base pay, variable pay, and recognition programs.
  • Employee Benefits: Access to best-in-class benefits, supportive policies, and wellbeing initiatives tailored to support you and your family throughout your career.
  • Continuous Learning: We are committed to your professional development through a culture of continuous learning, engaging work, and diverse experiences.

Diversity and Inclusion:

ICON is an equal opportunity and inclusive employer. We are committed to providing a workplace free of discrimination and harassment. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Accommodation:

If you require a reasonable accommodation due to a medical condition or disability during the application process or to perform essential job functions, please let us know.

Interested?

If you are interested in this role but feel you may not meet all the requirements, we encourage you to apply anyway. You might be exactly what we’re looking for at ICON, whether for this role or others.