Senior Clinical Trial Associate

MA, United States

Job description

Who we are:

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on delivering oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Kymera is also progressing degrader oncology programs that target undrugged or poorly drugged proteins to create new ways to fight cancer. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.

How we work:

  • PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
  • COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
  • BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

How you’ll contribute:

The Sr. Clinical Trial Associate (Sr CTA) is responsible for supporting the Development Operations Team to execute on clinical strategies to deliver successful operational outcomes per business requirements and in accordance with applicable regulations and guidance across multiple programs. They are responsible for coordination, logistics, tracking, and administrative tasks in support of clinical trials from protocol concept through clinical study report.

  • Works closely with internal development team members to aid in the execution of multiple Kymera sponsored clinical programs
  • Works closely with Clinical Trial Managers (CTMs) and legal to review and approve clinical trial agreements and site-specific study budgets
  • Assists CTMs in review of clinical trial documentation including, but not limited to Monitoring Visit Reports, Clinical Monitoring Plans, Communication Plans, Informed Consent Forms, Timelines, Essential Document Packets, etc.
  • Assists in the routing, tracking, and coordination of Site and CRO/Vendor Confidential Disclosure Agreements (CDAs) and other contracts with Clinical Operations, Legal, and Finance departments
  • Responsible for sponsor oversight checks, monitoring CRO quality checks, reconciliation of identified issues, and archiving of electronic Trial Master Files; Upon study completion coordinates eTMF transfer with CRO
  • Responsible for maintenance of internal SharePoint system
  • Responsible for drafting internal agendas and keeping meeting minutes as well as managing external partners in their execution of agendas and minutes
  • Responsible for set-up and management of ClinicalTrials.gov
  • Assists development team members with logistics coordination for investigator meetings and external vendor meetings
  • Responsible for study team roster maintenance and vendor contact lists
  • Participates in functional initiatives, including SOP development and review, staff training, and system/process improvement.

What skills and experience you’ll bring:

  • BS/BA or equivalent international degree in a scientific or health related field preferred 
  • A minimum of 3 years of direct experience in clinical trial execution 
  • Experience in Phase I II studies and global/international studies is advantageous
  • Knowledge and understanding of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) Guidelines
  • Excellent communication (verbal and written), organizational, and problem-solving skills
  • Experience building and managing external contract research relationships
  • Perform job duties with minimal supervision and guidance

Skills and experience not an exact match?:

Go ahead and submit your resume (and a cover letter, if you’d like!).  If this role isn't right for you, we can keep you in mind for future opportunities.

                                                                                                                                                                                  

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

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