Clinical Services Associate

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

As a Clinical Study Associate (CSA) you are part of the Clinical Services Management team and will support the Clinical Services Project Management Team through a varying packet of tasks linked to Sponsors Monitoring Visits (Study/site Qualification and Initiation Visits monitoring Visits Closure Visits Ad hoc Visits Monitoring Ad Hoc requests) and/or Pharma Partners audit. Your day will be filled with on site administrative tasks to always keep the Sponsors monitoring visits (before during and after visits) and /or Pharma Partners audit requests on Task on Track and on Time.

The Opportunity

• Coordinating and managing calendars: Ensures scheduling and alignment of time-sensitive activities including Site Initiation Visits (SIVs) Monitoring Visits Closing Visits and Audits while collaborating with relevant functions to maintain a smooth workflow.
• Preparing and maintaining study documentation: Manages laboratory and study documents to ensure compliance with Roche CDx CAP/CLIA Laboratory quality standards. Ensures Delegation of Authority (DOA) logs device accountability records good documentation practices (GDP) and study binders are updated and completed according to requirements. Works closely with the Lab Manager and team to provide accurate and timely maintenance records and documentation.
• Facilitating and supporting monitoring activities: Actively participates in Monitoring Visits to ensure activities are conducted efficiently following established study protocols and processes.
• Managing supplier questionnaire documentation: Completes and updates supplier questionnaires using existing data coordinates with Subject Matter Experts for timely follow-ups and oversees documentation maintenance and tracking of dates.
• Driving process improvements: Participates in process improvement initiatives to enhance operational efficiency and documentation practices within the Roche CDx CAP/CLIA Laboratory.

Who You Are

• You have a Bachelors Degree; preferably in life sciences nursing or a related field of study; or Business Administration (required)
• You have two years of administrative management and/or entry level CRA
• (clinical research associate) CTA experience required. A history of working with histo-technology laboratories is preferred but not required

Behaviors competencies and qualities of the ideal applicant.

• Demonstrating effective communication and technical proficiency: Communicates professionally in English both written and oral with additional language skills as a plus. Shows strong proficiency in Microsoft Office (Word Excel PowerPoint) and Google Tools to support tasks and project workflows.
• Manages multiple tasks with excellent organizational skills and maintains strong attention to detail while meeting deadlines. Thrives in dynamic environments by taking initiative adapting to change and displaying a positive and energetic attitude. Combines critical thinking and problem-solving abilities with the flexibility to work independently or collaboratively fostering a productive and service-oriented team environment.
• Demonstrates diligence commitment to accuracy and a focus on customer and Project Manager service by engaging internal stakeholders positively and professionally.
• Experience in cancer research knowledge of ICH-GCP guidelines for clinical trials and global work experience are considered advantageous.

Relocation benefits are not offered for this job position.

The expected salary range for this position in Tucson is $60000 - $84095 . Actual pay will be determined based on experience qualifications geographic location and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.

If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.

Required Experience:

IC