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[Contingent] Clinical Trial Associate, Clinical Operations, Infectious Disease
4 months ago
The Role:
The Clinical Trial Associate (CTA) provides clinical trial coordination support to Project Teams for assigned clinical trial(s).This support includes tracking a wide range of key operational activities and maintenance of essential study documentation, including the electronic Trial Master File (eTMF). with external vendors and CROs.The position reports to the Clinical Operations Head in the assigned Therapeutic Area and will work cross-functionally and collaboratively to support clinical operations activities.
Heres What Youll Do:
- Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day-to-day operational activities of assigned trials to ensure study objectives and timelines are met with quality, in compliance with applicable SOPs and regulatory guidelines
- Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems
- Liaise with Clinical Sample Management for the tracking and coordination of biomarker testing with 3rd party labs
- Collaborate with Clinical Data Management and Digital Informatics to ensure timely training and access to Moderna systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders (e.g., CRO and Clinical Site Staff)
- Coordinate Project Team and departmental meetings, including associated documentation
- Assist with vendor / clinical site agreements, budgets and reconciliation / tracking of purchase orders and invoices for assigned trials
- Develop and maintain strong, collaborative relationships with key stakeholders within Moderna, its CROs, and clinical sites
Heres What Youll Bring to the Table:
- At least 2 years of experience in a clinical research environment
- Bachelors degree in a science-based discipline preferred
- Basic understanding of drug development, including familiarity with FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Good verbal and written communication skills
- Good organizational skills and attention to detail
- Willingness to learn, able to take direction and ability to manage multiple tasks
- Self-motivated and comfortable with shifting priorities and change in a small company environment
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com . (EEO/AAP Employer)
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