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    Senior Clinical Research Associate/Cra Ii - Oncology Experience Required

    Kcr
    2+ years
    Not Disclosed
    Boston
    10 Aug. 20, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

    Company Overview:
    KCR is a global clinical development solutions provider with a focus on delivering exceptional service to biotechnology and pharmaceutical organizations. With offices across North America, Europe, and Australia, KCR operates in over 25 countries, offering comprehensive trial execution, consulting, and placement services. We are dedicated to optimizing clinical development to bring life-changing therapies to market. For more information, visit www.kcrcro.com.

    Position Summary:
    We are seeking experienced, dynamic Clinical Research Associates at the II and Senior I levels to join our growing US team. This role offers an opportunity to contribute to impactful oncology projects, with a focus on growth, training, and defined expectations. You will be supported by experienced managers and benefit from a collaborative and open work environment.

    Key Responsibilities:

    • Site Monitoring & Management:

      • Conduct site visits and monitoring activities according to protocol, GCP/ICH Guidelines, and other applicable regulations.
      • Ensure study integrity and adherence to guidelines, protocols, and regulations.
      • Perform pre-study, initiation, routine monitoring, and close-out visits.
      • Track site performance and ensure adherence to study deliverables.

    • Leadership & Development:

      • Lead, coach, and mentor CRA teams to enhance their skills and performance.
      • Develop and implement training programs for CRAs and other staff.
      • Oversee execution of KPIs for assigned staff and manage site deliverables within required timeframes and budgets.

    • Project Contribution:

      • Actively contribute to project teams with feedback and suggestions to ensure successful project completion.
      • Support the development and improvement of training programs and processes.

    Requirements:

    • Education & Experience:

      • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or Nursing from an accredited institution.
      • At least 2 years of independent monitoring experience, including pre-study, initiation, routine monitoring, and close-out visits.
      • Minimum of 1 year of oncology and early phase experience as a CRA.

    • Skills & Competencies:

      • Deep knowledge of clinical trial processes and monitoring procedures.
      • Proficient with new technologies and computer systems.
      • Fluent in English (both written and spoken).
      • Strong organizational skills and ability to complete tasks accurately and timely.
      • Ability to travel up to 70% of the time.

    Benefits:

    • Paid Time Off: 33 PTO days (including recognized holidays) plus 1 additional day for your birthday.
    • Healthcare & Wellbeing: Comprehensive benefits package including private health plans, life insurance, travel insurance, disability insurance, and a private retirement fund.
    • Additional Benefits: Loyalty and referral programs, advanced technology and equipment, and an open culture with direct access to management.
    • Training & Development: Onboarding process, sector-specific training, and mentoring programs.

    Diversity & Inclusion:
    At KCR, we are committed to fostering an inclusive and respectful workplace. We value diverse perspectives and strive to create a culture where all employees can thrive. KCR is an equal opportunity employer and maintains a non-discriminatory work environment.

    Privacy Policy:
    Your data will be processed according to KCR Group Privacy Policy. For details, visit KCR Privacy Policy. If you have any questions or concerns, contact our Data Protection Officer at gdpr@kcrcro.com.

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