Clinical Study Associate (Hybrid)

Clinical Study Associate

Are you a recent college graduate ready to start your career in the field of biotech? 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. 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 the clinical research industry, we want to hear from you!

Summary

As a CellCarta Clinical Study Associate (CSA) you are part of the Clinical Operations team and will support the Project manager through a varying packet of tasks linked to sample review, querying, and release for testing as well as tasks linked to study conduct and/or set-up. Your day will be filled with administrative tasks thereby embodying 3T’s i.e. always keep the project on Task, on Track and on Time.

Roles & 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 Result Reporting
• Support with ad hoc (Batch) Test Assignment
• Support with signature collection, audits, document filing, etc
• Support with Monitor Visits

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

• Experience in 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; other languages desirable
• 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
• Ability to work independently and as a team member
• Possesses critical thinking and problem solving skills
• Customer and Project Manager service oriented

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.
• Hybrid work schedule.

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!

We offer a wide range of benefits including:

• Competitive wages: $40,000 - 50,000
• Medical, dental, and vision benefits
• 401k retirement savings plan with a healthy match
• Vacation and sick time
• Career development opportunities
• Continuing education

About Us

CellCarta is a rapidly growing, stable company. We are a leading provider of pre-clinical and clinical trial services to pharmaceutical and biotechnology companies. Our laboratory service offerings include immunohistochemistry, FISH, CTC isolation and characterization, chemosensitivity testing, tissue procurement, flow cytometry, ELISA, mutation testing, cell expansion, and colony-forming assays. CellCarta is a CLIA-licensed and CAP-accredited laboratory, and we perform studies in compliance with the relevant portions of Good Laboratory and Good Clinical Practices.

Join us as we make an impact on the future of patient therapy!

Supplemental Information

Candidates must be legally authorized to work in the United States on a permanent basis. Verification of employment eligibility will be required at the time of hire. Visa sponsorship is not available.

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].