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    Cra - Clinical Trial

    Lambda Therapeutic Research
    0-3 years
    Not Disclosed
    Ahmedabad
    10 Aug. 13, 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 Details

    Responsibilities:

    • Site Identification & Feasibility: Conduct feasibility studies and identify suitable sites for clinical trials.
    • Site Visits: Perform site selection visits, site initiation visits, site monitoring visits, and site close-out visits in compliance with the protocol, applicable regulatory guidelines, and local regulations.
    • Documentation: Send follow-up letters to sites and submit visit reports to the Clinical Team Leader/Project Manager.
    • Site Management: Maintain close association with sites for patient recruitment, patient follow-up, and protocol-related activities.
    • Communication: Act as a liaison between the sponsor and the site, ensuring accurate and timely communication.
    • Training: Train investigators on the protocol and relevant regulatory guidelines.
    • Ethics & Regulatory: Submit to the Ethics Committee and assist in the preparation of the regulatory binder.
    • Site Files: Maintain updated site files, collect essential and project-related documents during site visits, and maintain the central clinical file.
    • CRF Retrieval: Retrieve Case Report Forms (CRFs) as per project instructions.
    • Study Materials: Coordinate and distribute clinical study materials to study sites.
    • Archival: Archive study documents.

    Key Deliverables:

    • Successful site identification and feasibility assessments.
    • Compliance with protocol and regulatory guidelines for all site visits.
    • Accurate and timely documentation and communication.
    • Effective training and support for investigators.
    • Proper maintenance and archival of study documents and site files.

    Allied Responsibilities:

    • Perform additional tasks as assigned by the Clinical Team Leader or Project Manager.

    Experience:

    • Relevant experience in clinical trial site management and monitoring.

    Educational Qualification:

    • Degree in Life Sciences, Clinical Research, or a related field.

    Competencies:

    • Accountability: Taking ownership of tasks and responsibilities.
    • Communication: Clear and effective verbal and written communication skills.
    • Work Ethic: Demonstrates reliability and dedication.
    • Initiative: Proactively addressing challenges and seeking improvements.
    • Leadership: Guiding and motivating team members.
    • Technical Knowledge: Understanding of clinical trial processes and regulatory guidelines.
    • Motivation/Initiative: Drive to achieve results and improve processes.
    • Interpersonal/Leadership Skills: Ability to build relationships and lead teams.
    • Presentation/Communication Skills: Skill in presenting and communicating information.
    • Organizational Culture Fit: Alignment with company values and culture.
    • Flexibility/Planning & Organizing: Adaptability and effective management of tasks.

    Accomplishments & Strengths:

    • Demonstrated achievements in site management and trial coordination.
    • Effective management of site relationships and regulatory compliance.

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