Clinical Study Associate

Clinical Study Associate I

Are you a motivated individual with a passion for clinical research? Do you want to be part of a team that is making a real difference in improving human health? If so, we have the perfect opportunity for you! CellCarta is seeking an entry-level Clinical Study Associate to join our innovative and dynamic team in Naperville, Illinois. As a leading clinical research company, we are committed to advancing medical science and improving patient outcomes. If you are ready to jump-start your career in clinical research, we want to hear from you!

Summary

As a Clinical Study Associate (CSA I), you are part of the Clinical Operations team and will support the Project Manager through a variety of tasks linked to sample review, querying, and release for testing, as well as tasks related to study conduct and/or set-up. Your day will be filled with administrative tasks, thereby embodying the 3Ts: always keeping the project on Task, on Track, and on Time.

Responsibilities

1. Sample review and release

• Review of patient sample documentation to check if sample conforms to study-specific guidelines
• Preparation of data queries in case missing or conflicting information is found
• Follow up of answered queries
• Release samples in the correct testing flow
• Collaborate close with the biosample management and project management team

2. Study conduct

• Keep study account information up to date within a Laboratory Inventory Management System (LIMS - StarLIMS) and Customer Portal 
• Prepare shipment requests through LIMS (StarLIMS) 
• Support with image transfer requests
• Prepare BioAnalytical Reports for review by the Project Manager
• Support with study closure activities 
• Support with Data Entry in systems like Medrio
• Support with signature collection, audits, document filing, etc

3. Study set-up

• Preparation of applicable study documentation ensuring that all processes from sample accessioning up to result reporting can run smoothly.
• Completion of the study set-up within a Laboratory Inventory Management System (LIMS - StarLIMS). This includes but is not limited to: preparation of flows for automated test assignment, devising of quality controls to check that samples meet study-specific requirements.

Required education 

• A Bachelor degree preferably in life sciences, nursing or a related field of study; Business Administration or similar expertise through experience.

Qualification and Skills

• 2+ years of administrative management, and/or CRA (clinical research associate), CTA experience, or a history of working with histo-technology laboratories preferred but not required
• Strong communication skills, proficient in English language, both written and oral communications
• Proficient in Microsoft Office (Word, Excel, PowerPoint)
• Excellent organizational skills and able to multi-task
• Positive and energetic attitude
• Able to take initiative, be adaptable, and strive in a dynamic environment
• Strong attention to detail and commitment to delivering accurate results
• Diligent and conscientious
• Ability to work independently and as a member
• Possesses critical thinking and problem solving skills
• Customer and Project Manager service oriented
• Communicate effectively with various internal stakeholders in a positive and professional manner

It's a bonus if you have: 

• Experience in cancer research 
• Have a working knowledge of ICH-GCP guidelines related to clinical trials
• Worked in global locations

Working Conditions

• Monday through Friday, 9am - 5pm
• Flexible hybrid working

Benefits
CellCarta is made up of dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world! 

What can we offer

• Competitive wages: $40,000 - $45,000
• Medical, dental, and vision benefits
• 401k retirement savings plan with a healthy match
• Vacation and sick time
• Career development opportunities
• Continuing education

About CellCarta

CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.

Joining CellCarta means working with dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world!

Join us as we make an impact on patient therapy!

The information collected to review your application will be processed by the human resources services of CellCarta Biosciences Inc. and its affiliates (collectively, “CellCarta”). The legal basis for this processing is the legitimate interest of CellCarta to evaluate the suitability of candidates for the roles available at CellCarta.

CellCarta will only process that information which is necessary to evaluate your application. This information includes identifying information such as your name, address, email address and phone number, as well as information about your education and professional experience, including previous positions and your CV. Such information is required for us to complete your applicant file, assess your suitability for the role and comply with applicable laws. CellCarta may obtain personal information from other sources, such as during reference, background, or employment checks, with your permission, and from third party sources such as recruitment and assessment sites or professional social media sites, in each case only if such information is relevant to reviewing your application. Your personal information will be retained only for so long as reasonably necessary and in accordance with applicable laws. This information will be processed confidentially and only accessed by those who have a need for the recruitment process. Please note that the information comprising your applicant file may be processed in a country that is not where you are located (for example, you might be in the European Economic Area or Québec, Canada, whereas your applicant file may be reviewed by CellCarta in the United States). If you are offered and accept employment with CellCarta Biosciences Inc. or one of its affiliates, the information collected will become part of your employment record. If you do not want us to retain your information, or want us to update it, please contact [email protected] .