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    Clinical Research Associate

    Lambda Therapeutic Research
    3+ years
    Preferred by Comapny
    Ahmedabad
    10 Nov. 24, 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 Research Associate (Clinical Trial)

    Location: Ahmedabad, India
    Company: Lambda Therapeutic Research Ltd.

    Organisational Overview

    Lambda Therapeutic Research Ltd. is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad, India. Lambda provides end-to-end clinical research services to the pharmaceutical, biotech, and generic industries. The company is known for its excellence in clinical trial management and regulatory compliance across international markets.

    Position Overview

    The Clinical Research Associate (CRA) will be responsible for supporting clinical trials by ensuring the successful planning, initiation, execution, and close-out of clinical research studies. This includes facilitating site operations, maintaining regulatory compliance, and ensuring quality standards are met throughout the study lifecycle.

    Key Responsibilities

    Site Management & Monitoring

    • Attend and facilitate Investigators’ Meetings, ensuring proper understanding of the study protocol.
    • Train Investigators on the protocol and relevant regulatory guidelines, including local regulations.
    • Conduct site visits, such as Site Selection, Site Initiation, Site Monitoring, and Close-out Visits, ensuring compliance with protocol and applicable regulations.
    • Coordinate with study sites for patient recruitment, follow-up, and other protocol-related activities.
    • Ensure the proper management and compliance of all study-related documents and data.
    • Maintain accurate and timely communication between Lambda Therapeutic Research and the study site.
    • Ensure calibration of all equipment used at sites before and during the trial and maintain traceability in source data.

    Documentation & Reporting

    • Submit Follow-up Letters and Visit Reports to the Clinical Team Leader/Project Manager as required.
    • Maintain updated Site Files and Site Master Files for the project, ensuring proper documentation is collected during visits.
    • Conduct CRF retrieval and e-CRF review as per the project management plan.
    • Ensure archival of study documents, following SOPs and project management instructions.

    Communication & Coordination

    • Act as a communication link between Lambda Therapeutic Research and the site.
    • Ensure timely and effective sponsor/site communication and correspondence.
    • Coordinate and distribute clinical study materials to sites.

    Experience & Qualifications

    Experience

    • At least 4 years of experience in clinical research, specifically in monitoring clinical sites.

    Educational Qualifications

    • A science graduate is required, preferably with a B.Pharm, M.Pharm, MSc, BHMS, or BAMS degree.

    Key Competencies

    • Accountability: Ability to take ownership of tasks, ensuring all responsibilities are completed within deadlines.
    • Communication: Strong verbal and written communication skills to maintain effective interactions with sites, sponsors, and internal teams.
    • Work Ethic: A strong sense of responsibility and dedication to ensuring the success of clinical trials.
    • Initiative: Proactive in managing tasks and addressing challenges without constant supervision.
    • Leadership: Ability to guide sites and team members while maintaining strong collaboration.
    • Technical Knowledge: Deep understanding of clinical trial operations, regulatory guidelines, and monitoring techniques.
    • Organizational Skills: Effective in managing multiple priorities and tasks in a fast-paced environment.
    • Flexibility/Planning & Organizing: Ability to adapt to changes and effectively organize work to meet deadlines.

    Why Join Lambda?

    As a Clinical Research Associate at Lambda Therapeutic Research, you will be an integral part of a dynamic team, contributing to the success of clinical trials across the globe. This role offers excellent professional growth opportunities in the clinical research field, with exposure to cutting-edge projects in an innovative and compliance-driven environment.

    Lambda Therapeutic Research Ltd.

    Join us in advancing clinical research to improve healthcare outcomes worldwide.

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