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Clinical Research Coordinator Ii

2-4 years
Not Disclosed
10 Feb. 11, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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

Job Title: Clinical Research Coordinator II

Experience Level: 2-4 Years

Application Email: careers@clinztech.com


Job Summary

ClinzTech is seeking a Clinical Research Coordinator II (CRC II) with 2-4 years of experience to support and oversee clinical research studies. The ideal candidate will coordinate study protocols, patient recruitment, regulatory compliance, and data collection while ensuring adherence to Good Clinical Practice (GCP) guidelines and clinical trial regulations.

This role requires a strong understanding of clinical research processes, attention to detail, and the ability to collaborate with investigators, sponsors, and regulatory bodies.


Key Responsibilities

Study Coordination & Compliance

  • Manage day-to-day operations of clinical research studies.
  • Ensure compliance with study protocols, GCP, FDA, ICH, and IRB regulations.
  • Assist in study start-up, site selection, and initiation visits.
  • Prepare and maintain study documentation, including case report forms (CRFs), consent forms, and regulatory submissions.

Patient Recruitment & Monitoring

  • Identify and recruit eligible participants for clinical trials.
  • Conduct informed consent processes, ensuring patients understand study details.
  • Monitor patient safety, adverse events, and compliance with study protocols.
  • Maintain accurate source documentation and electronic medical records (EMR).

Regulatory & Data Management

  • Ensure proper documentation, data integrity, and confidentiality of patient records.
  • Coordinate with IRB/ethics committees for protocol approvals and amendments.
  • Assist in data collection, query resolution, and report generation.
  • Prepare for site audits and sponsor inspections.

Collaboration & Communication

  • Work closely with principal investigators (PIs), sponsors, contract research organizations (CROs), and clinical teams.
  • Provide study updates, training, and protocol adherence guidance to staff.
  • Assist in budget management, sponsor invoicing, and financial tracking.

Qualifications & Requirements

Education:

  • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related field.
  • A Master’s degree or certification in Clinical Research (SOCRA, ACRP, or equivalent) is a plus.

Experience:

  • 2-4 years of experience in clinical research coordination, clinical trials, or site management.
  • Prior experience with Phase I-IV clinical trials is preferred.

Technical & Clinical Skills:

  • Strong knowledge of GCP, FDA, ICH, and IRB regulatory guidelines.
  • Experience with Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) platforms.
  • Proficiency in Microsoft Office (Excel, Word, PowerPoint) and medical record systems (EMR/EHR).

Soft Skills:

  • Detail-oriented and highly organized to manage multiple trials simultaneously.
  • Excellent communication and interpersonal skills for patient interaction and team collaboration.
  • Problem-solving abilities to address protocol deviations and regulatory issues.
  • Ability to work independently and in a fast-paced research environment.

Preferred Qualifications

  • Experience in oncology, cardiology, infectious diseases, or rare disease clinical trials.
  • Familiarity with budgeting, grant writing, and financial management in research.
  • Certification as a Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP).

Benefits & Growth Opportunities

  • Competitive salary and performance-based incentives.
  • Comprehensive healthcare and wellness benefits.
  • Opportunities for career advancement into senior clinical research roles.
  • Exposure to cutting-edge clinical trials and innovative research methodologies.

How to Apply

Interested candidates should email their CVs to careers@clinztech.com with the subject line: Clinical Research Coordinator II Application – [Your Name].

For more information about ClinzTech, visit Company Website.