Clinical Research Associate

2 weeks 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, providing essential support to the Clinical Services Project Management Team. Your responsibilities will encompass a variety of tasks associated with Sponsor's Monitoring Visits, including Study/site Qualification and Initiation Visits, Monitoring Visits, Closure Visits, and Ad hoc Visits, as well as Pharma Partner's audits.

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


Key Responsibilities:
The CSA is tasked with executing specific assignments under the guidance of the study Project and/or Program Managers. These assignments are time-sensitive and will be monitored closely. The CSA guarantees that all activities are conducted in compliance with the Roche CDx CAP/CLIA Laboratory quality system. Collaboration with Quality, Roche CDx CAP/CLIA Laboratory, and Pathologist is essential. 1.

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

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

Ensures that Delegation of Authority (DOA) Logs are current, verifies that personnel listed on the DOA have completed necessary training, and ensures that device accountability logs are maintained punctually. Good documentation practices (GDP) must be adhered to by laboratory personnel in all paper documentation, and device registration study binders must be kept up to date according to study requirements.

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

Supplier Questionnaire Management:

Completes supplier questionnaires utilizing previously gathered information and ensures timely follow-up with relevant Subject Matter Experts to finalize documents. Responsible for maintaining and managing questionnaire timelines and document upkeep. 5. Engage in process improvement initiatives 6. Additional responsibilities may be assigned by Clinical Services Management.

Educational Requirements:

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

Qualifications and Skills:

  • Minimum of 2 years in administrative management, entry-level CRA (Clinical Research Associate), or CTA experience, preferably with a background in histo-technology laboratories.
  • Excellent communication skills, with proficiency in English, both written and verbal; knowledge of additional languages is a plus.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and Google Tools.
  • Strong organizational skills with the ability to manage multiple tasks simultaneously.
  • A positive and energetic demeanor.
  • Ability to take initiative, adapt, and thrive in a dynamic work environment.
  • Keen attention to detail and a 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 abilities.
  • Customer-focused and service-oriented towards Project Managers.
  • Ability to communicate effectively with various internal stakeholders in a professional and positive manner. Bonus qualifications include:
  • 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 without regard to 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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