Clinical Consent Sr. Specialist, Clinical Biomarkers at ModernaTX, Inc. in Cambridge, Massachusetts

Job Description:

The Role:


Moderna is currently seeking an experienced and highly motivated Clinical Consent Sr. Specialist


who is eager to develop their career in a fast-paced company.


The successful candidate will be responsible for editing and writing informed consent language for clinical biomarker research and biobanking across Moderna's clinical protocols in accordance with institutional policies, federal regulatory standards, and ease of understanding by research participants.


This will include executing on all activities related to informed consent of biospecimens and data collected as part of the Moderna's clinical trials.


The Clinical Consent Sr. Specialist will interact closely with stakeholders and continuously make improvements to related documents based on content, language, complexity, and reading level.


Here's What You'll Do:

• Act as subject matter expert (SME) in patient informed consent and regulatory topics to ensure adherence to local laws/regulations/requirements for biomarker research and biobanking
  
  


• Serve as biomarker contact for study-related inquiries from HAs/IRBs/ECs regarding biospecimens and biomarker objectives and negotiate related consent language
  
  


• Develop process to verify informed consent documents against protocols, re-writing and/or informing authors of any important missing information and inconsistencies.
  
  


• Use industry knowledge to monitor external trends that will affect biospecimen consent language and best practices regarding content, process and approach.
  
  


• Lead development and updating of ICFs, as well as policies, standard operating procedures (SOPs) and working procedures related to consent oversight.
  
  


• Manage development of a supplemental consent database for each clinical study.
  
  


• Maintain editorial integrity of Moderna's informed consent templates and guidance documents.
  
  


• Work independently (if applicable) on special research initiatives.
  
  

Here's What You'll Bring to the Table:

• University degree required, and at least 5 years of experience in clinical research.
  
  


• Experience working in the pharmaceutical industry and/or consumer health publishing
  
  


• Experience reviewing, drafting and negotiating a variety of contracts in the biotechnology and/or pharmaceutical industry is beneficial.
  
  


• Exceptional judgment and ability to identify, prioritize, and resolve issues quickly and independently.
  
  


• Experience working in a regulated environment, with at least a basic understanding of the regulations relevant to the protection of human research participants, including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations, and the Health Insurance Portability and Accountability Act (HIPAA).
  
  


• Ability to work independently while managing multiple priorities in a timely and effective manner.
  
  


• Flexibility to work in a fast-paced, dynamic environment.
  
  

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options


• Flexible Spending Accounts for medical expenses and dependent care expenses


• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities


• Family care benefits, including subsidized back-up care options and on-demand tutoring


• Free premium access to fitness, nutrition, and mindfulness classes


• Exclusive preferred pricing on Peloton fitness equipment


• Adoption and family-planning benefits


• Dedicated care coordination support for our LGBTQ+ community


• Generous paid time off, including:
  • Vacation, sick time and holidays
  • Volunteer time to participate within your community
  • Discretionary year-end shutdown
  • Paid sabbatical after 5 years; every 3 years thereafter


• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents


• 401k match and Financial Planning tools


• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options


• Complimentary concierge service including home services research, travel booking, and entertainment requests


• Free parking or subsidized commuter passes


• Location-specific perks and extras!

About Moderna



Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure 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 people are 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. We're 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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