Clinical Research Coordinator Ii

2-4 years

Not Disclosed

Hyderabad

10 Jan. 23, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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 Required: 2 – 4 Years

Location: [Specify Location]

Job Description:

We are seeking a highly organized and experienced Clinical Research Coordinator II to join our team. The ideal candidate will have 2 to 4 years of experience in clinical research, with a solid understanding of clinical trial operations, regulatory requirements, and patient management. As a Clinical Research Coordinator II, you will be responsible for overseeing the day-to-day activities of clinical trials, ensuring they are conducted efficiently, in compliance with regulatory guidelines, and within the scope of the study protocols.

Key Responsibilities:

Coordinate and manage the daily operations of clinical research studies, including recruitment, screening, and enrollment of study participants.
Ensure compliance with study protocols, regulatory requirements (e.g., ICH-GCP, FDA regulations), and internal SOPs.
Perform clinical assessments and collect, record, and maintain study data with accuracy and confidentiality.
Monitor patient progress and assist with patient visits, including informed consent process, sample collection, and follow-up activities.
Work closely with Principal Investigators (PIs), research teams, and sponsors to ensure the successful execution of clinical trials.
Maintain clinical trial documentation, including case report forms (CRFs), source documents, and regulatory binders, ensuring compliance with Good Clinical Practice (GCP).
Manage investigational product(s), including tracking inventory, storage, and distribution in accordance with study protocols.
Assist in the preparation and submission of regulatory documents (e.g., IRB/IEC submissions, safety reports).
Monitor study milestones and timelines, ensuring studies are completed on schedule and within budget.
Conduct study close-out activities, including ensuring the collection of all necessary documentation and data.
Provide training and support to junior research staff and new team members on study processes and compliance.
Communicate with study participants, ensuring they are informed and supported throughout the trial process.
Prepare and participate in sponsor and regulatory audits, ensuring compliance with audit requirements.

Qualifications:

Bachelor’s degree in Life Sciences, Nursing, or a related field.
2-4 years of experience in clinical research, with a strong understanding of clinical trial processes, regulations, and documentation.
Knowledge of ICH-GCP guidelines, FDA regulations, and other regulatory bodies governing clinical trials.
Strong communication and interpersonal skills, with the ability to interact effectively with patients, research teams, and sponsors.
Ability to manage multiple tasks and prioritize responsibilities in a fast-paced environment.
Proficiency in Microsoft Office Suite and clinical trial management systems (CTMS).
Ability to work independently as well as collaboratively within a team environment.
Strong attention to detail and organizational skills, with the ability to maintain accurate and complete records.
Certification in Clinical Research (e.g., ACRP, SOCRA) is a plus.

This is an excellent opportunity for a Clinical Research Coordinator with experience to grow and advance their career in clinical research. If you are passionate about improving patient outcomes and ensuring clinical trial success, we encourage you to apply.

Rush your CVs to : careers@clinztech.com

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Clinical Research Coordinator Ii

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