Senior Clinical Trial Associate

Location
San Diego, California
Posted
Oct 03, 2021
Ref
oqmtgfwf
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

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Company Overview

Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.

Job Summary

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.

Essential Duties and Responsibilities (including but not limited to):
  • 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
  • Responsible for the set up and maintenance of the electronic Trial Master Files (eTMF) according to eTMF Plan
  • Supports the development of eTMF processes and plans
  • Serves as the eTMF Super User and primary point of contact for eTMF-related support
  • Confirms appropriate training and access for the various eTMF user roles and permissions
  • 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), under the direction of the CTM (or designee), to ensure that the eTMF is audit/inspection ready
  • Assist or support with the collection and review    of essential documents
  • 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
  • Performs other duties as assigned by management

Qualifications Minimum Required:

  • Associates degree at a minimum or equivalent
  • Minimum of 3 years of clinical research experience or proven competencies for this position
  • Minimum of 1 year of eTMF experience

Other Required:

  • 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

Preferred:

  • Experience as a CTA
  • University degree preferred

Competencies:

  • Demonstrates a working knowledge of ICH/GCP and clinical research processes
  • Solid 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
  • 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

 
Avidity is committed to complying with federal, state and local law on employee vaccinations.  Job candidates should be aware that full vaccination against COVID-19 may be required in the future.    Avidity is an equal opportunity employer and encourages potential or current employees to request a reasonable accommodation under federal, state and local regulations, should one be needed.