Clinical Study Administrator

2 weeks ago

Tucson, Arizona, United States Revel IT Full time
To Apply for this Job Click Here

Revel IT is seeking a dedicated Clinical Study Associate to join our dynamic team. In this role, you will be an integral part of the Clinical Services Management team, providing essential support to the Clinical Services Project Management Team through a diverse range of responsibilities related to Sponsor's Monitoring Visits and Pharma Partner's audits.

Job Overview:

  • Your daily activities will involve on-site administrative duties aimed at ensuring that the Sponsor's monitoring visits and Pharma Partner's audit requests are managed efficiently and effectively.

Key Responsibilities:

  • The Clinical Study Associate will be accountable for executing specific tasks, under the guidance of the study Project and/or Program Managers.
  • These tasks are time-sensitive and will be monitored closely.
  • Ensure that all activities comply with the Roche CDx CAP/CLIA Laboratory quality system.
  • Collaborate closely with Quality Assurance, Roche CDx CAP/CLIA Laboratory, and Pathologists.
  • Manage calendars to coordinate schedules for Site Initiation Visits, Monitoring Visits, Closing Visits, and Audits.
  • Maintain and prepare laboratory and study documentation for auditors, ensuring compliance with regulatory standards.
  • Keep Delegation of Authority (DOA) Logs current, ensuring that all personnel listed have completed necessary training.
  • Work alongside the Lab Manager to ensure timely provision of documentation and updates on personnel responsibilities.
  • Facilitate and participate in Monitoring visit activities.
  • Manage Supplier Questionnaire Documents, ensuring timely completion with input from Subject Matter Experts.
  • Oversee the maintenance of questionnaire dates and documentation.
  • Engage in process improvement initiatives as required.
  • Additional responsibilities may be assigned by Clinical Services Management.

Required Qualifications:

  • A Bachelor’s degree in life sciences, nursing, or a related field is preferred.
  • Experience in Business Administration or a similar field is advantageous.

Experience:

  • At least 2 years of experience in administrative management, entry-level CRA, or CTA roles, preferably with exposure to histo-technology laboratories.

Skills and Competencies:

  • Exceptional communication skills, proficient in English (both written and verbal); proficiency in additional languages is a plus.
  • Strong knowledge of Microsoft Office Suite (Word, Excel, PowerPoint) and Google Tools.
  • Excellent organizational abilities with the capacity to manage multiple tasks effectively.
  • A positive and energetic demeanor.
  • Ability to take initiative, adapt, and thrive in a fast-paced environment.
  • Meticulous attention to detail and a commitment to timely delivery.
  • Conscientious and diligent work ethic.
  • Ability to work independently as well as collaboratively within a team.
  • Strong critical thinking and problem-solving skills.
  • Customer and Project Manager service-oriented mindset.
  • Ability to communicate professionally and positively with various internal stakeholders.
  • Experience in cancer research and familiarity with ICH-GCP guidelines related to clinical trials is a bonus.
  • Experience working in global settings is also desirable.
To Apply for this Job Click Here

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