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    Senior Clinical Research Associate- Oncology

    Catalyst Clinical Research Llc
    3-7 years
    Not Disclosed
    Remote
    10 Sept. 18, 2024
    Job Description
    Job Type: Full Time Remote 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: Senior Clinical Research Associate

    As a Senior Clinical Research Associate, you will play a critical role in monitoring clinical trial programs and managing regional trial sites to support biological and pharmaceutical development initiatives. This position requires adherence to relevant regulations, including ICH/GCP and PhRMA guidelines, as well as Catalyst Clinical Research’s standard operating procedures (SOPs) and practices. You will collaborate closely with your assigned clinical research team to provide insights on site selection, study initiation, conflict resolution, and audit responses, while effectively communicating significant findings to in-house personnel.

    Key Responsibilities:

    • Travel up to 80% within your assigned territory to monitor clinical trials according to established plans, ensuring project goals are met. Conduct site evaluations, study initiations, routine monitoring, site close-outs, and prepare for FDA audits.
    • Enhance site selection by developing your territory to identify new research study sites.
    • Communicate effectively with site study staff and Catalyst personnel to report on study site status, disseminate information, and resolve study-related issues, including responding to audit findings.
    • Partner with your clinical project team and assist in planning/presenting Investigator Meetings, data collection, and FDA submission preparations.
    • Maintain a home office if working remotely, managing work activities efficiently to meet budgetary guidelines and project timelines.
    • Participate in internal and external meetings to stay informed about applicable regulations and guidelines.
    • Collaborate closely with the Study Manager and Project Manager to ensure smooth operations.
    • Provide internal support to Field Monitors through the assigned Clinical Trial Associate.
    • Work in conjunction with the extended study team, including the Sponsor, Vendors, Data Managers, Statisticians, Medical Monitors, and other trial staff.

    Qualifications:

    • Bachelor’s degree in a science or health-related discipline, or an equivalent of 7 years of industry experience.
    • Minimum of 5 years of clinical research experience, including direct site monitoring with a sponsor company or CRO, and at least 3 years of recent oncology clinical trial experience.
    • Strong knowledge of clinical trial monitoring, regulatory compliance, clinical research methodology, and all applicable regulations and guidelines.
    • Excellent organizational and time management skills, with the ability to work independently.
    • Strong communication and interpersonal skills.
    • Flexibility and willingness to travel routinely to meet project requirements.
    • Proficiency in standard computer applications.

    Note: Applicants must be authorized to work for any employer in the U.S. We cannot sponsor or take over sponsorship of an employment visa.

    About Catalyst Clinical Research, LLC:
    Catalyst Clinical Research is an equal opportunity employer. We celebrate diversity and are committed to fostering an inclusive environment for all employees.

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