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    Site Monitor Ii- Fsp

    Parexel
    3+ years
    Not Disclosed
    Remote, USA
    10 Aug. 16, 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

    Position Title: Site Monitor II (SM II)

    Job Purpose:

    The Site Monitor II (SM II) ensures data integrity and compliance with International Conference on Harmonization and Good Clinical Practice (ICH-GCP) and local regulations at the site level. This role involves monitoring activities in line with the Study Monitoring Plan (SMP), primarily through virtual methods with some on-site visits. The SM II will collaborate with Site Managers, Study Operations Managers (SOM), Global Study Managers (GSM), and Site Care Partners (SCP) to maintain compliance and ensure that the site is prepared for inspections.

    Key Responsibilities:

    • Oversight of Monitoring and Study Conduct:

      • Ensure compliance with regulatory requirements, ICH-GCP, and protocol. Evaluate site performance and site staff, providing recommendations and action plans for improvements.
      • Communicate and escalate significant issues to the project team promptly, developing and implementing action plans.
      • Verify that informed consent is properly obtained and documented for each subject.
      • Protect subject confidentiality and assess factors impacting subject safety and data integrity, including protocol deviations and pharmacovigilance issues.
      • Conduct monitoring activities both on-site and remotely as per the Clinical Monitoring Plan (CMP) or SMP.

    • Data Verification and Management:

      • Review and verify site source documents and medical records.
      • Ensure accuracy and completeness of clinical data entered in Case Report Forms (CRFs).
      • Manage protocol deviations, perform query resolution, and provide guidance to site staff to close queries within agreed timelines.
      • Perform Investigational Product (IP) inventory and reconciliation, ensuring proper dispensing and administration per protocol.

    • Documentation and Tracking:

      • Document activities via follow-up letters, monitoring reports, and communication logs as per SOPs and CMP/SMP.
      • Maintain up-to-date records of site personnel and ensure proper training compliance.
      • Track observations, ongoing status, and action items to resolution using data tracking systems.

    • Collaboration:

      • Work closely with the Site Manager and act as the primary liaison with site personnel.
      • Participate in Investigator Meetings and sponsor meetings, and attend global clinical monitoring and project staff meetings as required.

    • Process and Standards:

      • Guide site and project-level audit readiness and support preparation for audits and follow-up actions.
      • Mentor Site Monitor I (SM I) and assist in their development.

    • Compliance:

      • Adhere to required training, complete timesheets and expense reports accurately, and update CVs as necessary.
      • Maintain knowledge of and comply with Parexel processes, ICH-GCPs, and other relevant requirements.

    Skills:

    • Strong networking and relationship-building skills.
    • Effective communication with internal and external stakeholders.
    • Ability to adapt to new technologies and processes.
    • Proficiency in overcoming barriers in new process implementation.
    • Excellent verbal and written communication, presentation, and interpersonal skills.
    • Ability to build and maintain relationships with investigator site staff and other stakeholders.
    • Proficiency in relevant local languages and English.
    • Ability to manage travel of up to 75% regularly.

    Knowledge and Experience:

    • Minimum of 3 years’ experience as a clinical monitor, with expertise in virtual and on-site monitoring.
    • Experience with clinical trial management systems (e.g., Siebel CTMS), electronic Trial Master File (eTMF), and electronic Investigator Site File (eISF) (e.g., Florence).
    • Experience managing complex protocols, particularly in Oncology or other high-risk therapeutic areas.

    Education:

    • Bachelor’s degree or Registered Nurse (RN) in a related field, or equivalent combination of education, training, and experience.

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