What are the responsibilities and job description for the Senior Clinical Trial Associate (Sr. CTA) position at Avidity Biosciences?
Job Title: | Senior Clinical Trial Associate (Sr. CTA) |
Location: | San Diego, CA / Hybrid / Remote |
Position type: FLSA: | Full time Exempt |
Department: Finance ID: | Clinical Operations 7525-Q224-13 |
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 is responsible for supporting the daily workflow of clinical operations activities. The Sr. CTA provides administrative support to study teams throughout the study, serves as a mentor and coach for other CTAs, as applicable. 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.
- Serves as the eTMF Super User/System Administrator and primary point of contact for eTMF-related support.
- Confirms appropriate training and access for the various eTMF user roles and permissions, and grants eTMF access.
- Assists with eTMF system upgrades and patch releases, including reviewing contents of such upgrades and patch releases, performing User Acceptance Testing (UAT) as needed, and assisting with the change control process and documentation of such changes.
- Distributes eTMF queries to the clinical study team and follows up until resolution.
- Performs quality control of the documents/files as per study milestones outlined in the project plan and with CTM (or designee) oversight.
- Monitors eTMF trends and deficiencies to identify areas for progress and improvement.
- Provides metrics and ongoing status reporting on eTMF quality and completeness.
- Collaborates with the clinical study team (internally and external CROs/other vendors), under the direction of the CTM (or designee), to ensure that the eTMF is audit/inspection ready.
- Assists with preparations of essential document templates, collection, and review. Perform study tracking to ensure study files are current, accurate and complete.
- 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 etc.).
- Assists CTM (or designee) and cross-functional leaders in the production of various study reports and updates (i.e., country/site initiation, activation, recruitment).
- Assists in planning and organizing project-specific meetings including but not limited to internal clinical study team meetings, external service provider/partner meetings, CRA training, Investigator Meeting and PI meetings. Creates agendas, meeting minutes, and distributes.
- 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 support the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan.
- 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), coordinating tracking.
- May review, validate, track and file the essential documents for investigational sites as well as follows-up on missing/incomplete/invalid documents.
- May lead other CTAs to oversee QC process of eTMF per project plan.
- May mentor or assist with onboarding of new Clinical Trial Associate I and II new hires.
- Performs other duties as assigned by management.
What We Seek
- Bachelor’s Degree at a minimum or equivalent
- Minimum 3 years of industry experience within clinical research or proven competencies for this position
- Minimum 3 years of Trial Interactive eTMF experience, system administrator experience preferred
- Team leadership experience within a cross-functional matrix environment
- Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills
- Ability to travel as needed
- Demonstrates a working knowledge of ICH/GCP and clinical research processes
- Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders
- 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
- Ability to develop, coach and mentor CTA staff
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient
What We Will Provide to You
- The base salary range for this role is $114,000 - $126,000. 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.
Salary : $114,000 - $126,000
