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Clinical Research Associate
2 months ago
Job Overview:
As a Clinical Study Associate (CSA) at Nesco Resource, you will be an integral member of the Clinical Services Management team, providing essential support to the Clinical Services Project Management Team. Your role will encompass 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, as well as Pharma Partner's audits.
Your daily activities will involve on-site administrative tasks aimed at ensuring that all Sponsor's monitoring visits and Pharma Partner's audit requests are executed efficiently and punctually.
Key Responsibilities:
The CSA is tasked with the execution of specific duties, generally 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 and responsibilities are fulfilled in accordance with the Roche CDx CAP/CLIA Laboratory quality system. Collaboration with Quality, Roche CDx CAP/CLIA Laboratory, and Pathologist is essential. 1.
Calendar Coordination:
Facilitates scheduling 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 applicable personnel on the DOA have completed necessary training, maintains device accountability logs punctually, 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 per study requirements.
Works closely with the Lab Manager and/or representative to guarantee timely provision of documentation (e.g., obtaining maintenance records and logs from Lab instruments) and that new personnel are informed on DOAs. 3. Facilitate and/or participate in Monitoring visit 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, preferably in life sciences, nursing, or a related field; Business Administration or similar expertise through experience is also acceptable.
Qualifications and Skills:
- 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 positive and professional 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.
