Clinical Research Associate

1 week ago

Tucson, Arizona, United States Nesco Resource Full time

Job Overview:


As a Clinical Study Associate (CSA) at Nesco Resource, you will play a crucial role within the Clinical Services Management team, assisting the Clinical Services Project Management Team with a diverse range of responsibilities associated with Sponsor's Monitoring Visits, including Study/site Qualification and Initiation Visits, Monitoring Visits, Closure Visits, and Ad hoc Visits.

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 CSA is tasked with delivering specific responsibilities, typically overseen by the study Project and/or Program Managers. These tasks are time-sensitive and will be monitored closely. The CSA guarantees that all activities align with the Roche CDx CAP/CLIA Laboratory quality system. Collaborate closely with Quality, Roche CDx CAP/CLIA Laboratory, and Pathologist. 1.

Schedule Coordination:
Organizes schedules for SIV, Monitoring Visits, Closing Visits, and/or Audits. 2.

Documentation Management for Laboratory and/or Study Preparation for Auditors:

Ensures that Delegation of Authority (DOA) Logs are current, verifies that applicable personnel listed on DOA have completed necessary training, maintains device accountability logs in a timely manner, and ensures good documentation practices (GDP) are adhered to by laboratory personnel in paper documentation. Additionally, ensures that device registration study binders are updated and completed according to study specifications.

Work closely with the Lab Manager and/or representative to guarantee timely provision of documentation (e.g., maintenance records, logs, etc.) and ensure that new personnel are informed about DOAs. 3. Facilitate and/or participate in Monitoring visit activities.

Supplier Questionnaire Management:

Complete supplier questionnaires utilizing previously gathered information, ensuring timely follow-up with relevant Subject Matter Experts to finalize documents. Maintain and oversee questionnaire timelines and document upkeep. 5. Engage in process enhancement initiatives 6. Additional responsibilities may be assigned by Clinical Services Management.

Required Qualifications:

  • A Bachelor’s degree, preferably in life sciences, nursing, or a related field; Business Administration or equivalent experience is also acceptable.

Skills and Competencies:

  • 2 years of experience in administrative management, entry-level CRA (clinical research associate), or CTA experience, or a background in histo-technology laboratories is preferred but not mandatory.
  • Strong communication skills, proficient in English (both written and verbal); proficiency in additional languages is a plus.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and Google Tools.
  • Excellent organizational abilities and capacity to manage multiple tasks.
  • Positive and energetic demeanor.
  • Ability to take initiative, adapt, and thrive in a dynamic environment.
  • Strong attention to detail and commitment to timely delivery.
  • Diligent and conscientious work ethic.
  • Capability to work independently as well as collaboratively within a team.
  • Possesses critical thinking and problem-solving skills.
  • Customer and Project Manager service-oriented.
  • Effectively communicates with various internal stakeholders in a professional and positive manner. Bonus if you have:
  • Experience in cancer research.
  • Familiarity with ICH-GCP guidelines related to clinical trials.
  • Experience working in global settings.

Nesco Resource is committed to providing equal employment opportunities to all employees and applicants for employment, prohibiting discrimination and harassment of any kind based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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