Clinical Trial Associate II

Job Title:

Clinical Trial Associate II (CTA II)

Location:

San Diego, CA / Hybrid / Remote

Position type:

FLSA:

Full time

Non - Exempt

Department:

Clinical Operations

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 CTA II is responsible for supporting the daily workflow of clinical operations activities. The CTA II provides administrative support to study teams throughout the study.  Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting minutes, study document filing, maintaining study trackers, and oversight of the study-specific eTMF.

What You Will Contribute

• Serves as a member of the clinical operations team and provides administrative support and tracking of trial status, with the goal to contribute towards efficient management of trials
• Leads the onboarding effort for the eTMF
• Assists with the set-up and maintenance of the study specific eTMF, including updates to the configuration manual, index and required documents, inputting of site information, QC of documents, distributing/resolving queries, and running of reports.
• Supports the development of eTMF processes, plans, and supplemental training materials
• Identifies continuous improvement opportunities to enhance TMF operational efficiencies
• Serves as the primary point of contact for study specific eTMF-related support
• Confirms appropriate training and access for the various eTMF user roles and permissions
• Reviews metrics and ongoing status reporting on eTMF quality and completeness 
• Collaborates with the clinical study team (internally and external CROs and vendors), under the direction of the CTM (or designee), to ensure that the eTMF is audit/inspection ready
• Performs periodic eTMF completeness reviews and final eTMF completeness reviews according to the eTMF Plan, including the creation of associated placeholders for missing documents, tracking all findings until resolution.
• Assists or support eTMF audits and inspections.
• Assists with preparations of essential document templates, collection, and review. Perform study tracking to ensure study files are current, accurate and complete.
• May communicate directly with investigative sites to provide and obtain necessary regulatory documents, site status trackers and study supply needs.
• Provides administrative support to the clinical study team for study-related activities (e.g., maintenance of study mailbox, newsletter creation/review, study document formatting, binders, meeting minutes, tracking, etc.)
• Assists CTM (or designee) and cross-functional leaders in the production of various study reports and updates 
• Assists in planning and organizing project-specific meetings
• Creates and distributes meeting agendas and minutes.
• May act as point of contact for study-related requests for team members and service providers/partners
• May assist with study start-up activities, including feasibility, investigator recruitment, and general site management support under CTM (or designee) oversight
• May coordinate the distribution and the reconciliation of study material (Operations Manual, ISF, patient cards, etc.) as required by the study
• May support financial tasks for the study (e.g., investigator/institution/vendors payments)
• May mentor or assist with onboarding of new Clinical Trial Associate I new hires
• Performs other duties as assigned by management

What We Seek

• Bachelor’s degree at a minimum or equivalent
• Minimum of 3 years of clinical research experience or proven competencies for this position

•          Minimum of 2 years of eTMF experience

• Must have established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Ability to speak English proficiently
• Ability to travel domestically and internationally, including overnight stays
• Experience as a CTA
• Experience with Trial Interactive eTMF

 

Preferred:

• System Administrator level eTMF experience
• Demonstrates a working knowledge of ICH/GCP and clinical research processes
• Working knowledge and experience utilizing an eTMF platform(s)
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills, and maintain positive interactions with internal and external stakeholders
• Communicates both verbally and in written form in an efficient and professional manner
• Demonstrates values and a work ethic consistent with Company Values
• Exhibits high self-motivation, is detail-oriented, and able to work and plan independently as well as in a team environment

 What We will Provide to You:

• The base salary range for this role is $84,000 - $93,000 The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
• A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA

92121

O: 858-401-7900

F: 858-401-7901