Clinical Research Associate

0-2 years

₹22,985.98 - ₹39,131.51 per month

Mumbai

10 Oct. 15, 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, 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 Trial Coordinator

Job Type: Full-time, Entry-Level

Salary: ₹22,985.98 - ₹39,131.51 per month

About the Role:

As a Clinical Trial Coordinator, you will play a vital role in managing clinical trials from protocol development to site closure. Your responsibilities will include creating and writing trial protocols, training site staff, and ensuring compliance with regulatory guidelines.

Key Responsibilities:

Develop and present trial protocols to the steering committee.
Identify, evaluate, and establish trial sites, and manage site closure upon trial completion.
Train site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
Liaise with the ethics committee to ensure the rights, safety, and well-being of trial subjects.
Order, track, and manage investigational products (IP) and trial materials.
Oversee and document IP dispensing inventory and conduct reconciliation.
Protect subjects’ confidentiality, update their information, and verify that IP has been dispensed and administered per protocol.
Conduct regular site visits, coordinate project meetings, and write visit reports.
Implement action plans for sites that are not meeting performance expectations.
Liaise with regulatory authorities to ensure compliance.
Ensure adherence to SOPs, local regulations, ICH, and GCP guidelines.
Perform other tasks and responsibilities as needed.

Benefits:

Health insurance
Provident Fund

Schedule:

Day shift

Supplemental Pay:

Performance bonus
Yearly bonus

Work Location: In-person

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