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.
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