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Clinical Research Coordinator Ii

2-4 years
Not Disclosed
10 March 17, 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

Clinical Research Coordinator II
Company: Clinztech
Employment Type: Full-time
Experience Required: 2-4 years

Job Responsibilities:

  • Coordinate and oversee clinical trials to ensure compliance with regulatory guidelines and protocols.
  • Manage and monitor patient recruitment, enrollment, and retention for clinical studies.
  • Collect, document, and maintain clinical data and patient records according to Good Clinical Practice (GCP) standards.
  • Ensure compliance with IRB/EC approvals, FDA regulations, and sponsor requirements.
  • Assist in developing and maintaining study protocols, informed consent forms, and case report forms (CRFs).
  • Communicate with investigators, sponsors, regulatory authorities, and site personnel to ensure smooth study execution.
  • Monitor and report adverse events, deviations, and protocol violations as required.
  • Train and mentor junior research staff on clinical trial procedures and compliance.

Requirements:

  • Education: Bachelor's or Master’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
  • Experience: 2-4 years in clinical research coordination, clinical trials, or a similar role.
  • Skills:
    • Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
    • Experience in handling clinical trial documentation and regulatory submissions.
    • Excellent organizational, communication, and problem-solving skills.
    • Ability to work independently and collaborate with research teams.
    • Proficiency in clinical trial management software and EDC systems.

Preferred Qualifications:

  • Experience in Phase I-IV clinical trials.
  • Certification in Clinical Research (CCRC, ACRP, or SOCRA) is a plus.
  • Knowledge of sponsor or CRO interactions.

Why Join Clinztech?

  • Opportunity to work with leading clinical research experts.
  • Competitive salary and career advancement opportunities.
  • Exposure to cutting-edge clinical trials and research innovations.