What are the responsibilities and job description for the Senior Clinical Trial Associate position at Avidity NanoMedicines?
Description
Job Title :
Senior Clinical Trial Associate
Location : Remote
Position type : FLSA :
Full time
Exempt
Department : Finance ID :
Clinical Operations
7525-Q224-14
Strive to Bring a Profound Difference to our Patients
At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.
Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases : myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.
The Opportunity
The Sr. CTA plays a critical role in supporting unblinded clinical operations activities, ensuring efficient workflows and administrative excellence throughout the study lifecycle. This role involves mentoring other unblinded CTAs, managing key administrative tasks, and overseeing the unblinded electronic Trial Master File (eTMF). The Sr. CTA contributes significantly to maintaining quality standards and ensuring compliance with audit / inspection readiness requirements.
What You Will Contribute
- Collaborate with the unblinded clinical operations team to streamline trial activities and ensure efficient management of trials.
- Provide administrative support for unblinded clinical study teams, including managing study mailboxes, creating newsletters, formatting study documents, and preparing meeting materials such as agendas and minutes.
- Organize and facilitate unblinded meetings (internal and external), ensuring agendas, minutes, and follow-ups are completed.
- Assist with unblinded study start-up activities, including site management support under the direction of the unblinded Clinical Trial Manager (CTM).
- Serve as the unblinded eTMF Super User / System Administrator and primary point of contact for eTMF-related support.
- Lead the setup, configuration, and ongoing maintenance of the study-specific unblinded eTMF, including updates to configuration manuals, QC of documents, and resolution of queries.
- Ensure training, role assignments, and access permissions for all unblinded eTMF users.
- Distribute and track eTMF queries, ensuring timely resolution and quality control aligned with study milestones.
- Monitor eTMF trends and deficiencies, providing metrics and actionable insights for continuous improvement.
- Mentor and coach unblinded Clinical Trial Associates (CTAs), assisting in onboarding and professional development.
- Oversee the quality control process for unblinded eTMF, ensuring consistency and adherence to project plans.
- Support the development and improvement of unblinded eTMF processes, plans, and supplemental training materials.
- Provide metrics and ongoing status reports on eTMF quality and completeness, ensuring audit / inspection readiness.
- Assist in planning and executing system upgrades and patch releases, including User Acceptance Testing (UAT) and documentation of changes.
- Act as a point of contact for unblinded study-related requests from team members and service providers / partners.
- Collaborate with internal and external stakeholders to ensure successful trial execution and management.
What We Seek
What We will Provide to You :
Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego, CA
92121
O : 858-401-7900
F : 858-401-7901
Salary : $114,000 - $126,000
