Clinical Trial Assistant/Senior Clinical Trial Assistant

Location
Redwood City, CA
Posted
Mar 18, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
This position has responsibility to support the conduct of clinical trials, handling administrative aspects
of clinical trial execution and tracking the progress of clinical trials. The position coordinates and tracks
all study documentation including regulatory documents, study drug documents and clinical trial
payments.
What you'll do:
  • Provide support in project-specific tasks and the overall management of clinical trials to the Clinical Operations Department.
  • Assist in the coordination, organization of study management team meetings, sponsor and site, vendor teleconferences, including writing and distributing meeting minutes and agendas.
  • Assist with the planning and logistics of formal meetings including investigator meetings.
  • Develops study tools and guidelines to be utilized by study sites
  • Understands study timelines and manages sites and vendors to meet timelines
  • Contributes to writing informed consent templates, protocol and/or other documents. Applies knowledge of regulatory requirements/SOPs to documents
  • Coordinates (as needed) and reviews regulatory documents from study sites; ensures completeness and accuracy
  • Ensures study records are auditable both at investigational sites and in-house
  • Assists study manager with the vendor invoice review and payment process
  • Communicates status of trial to manager and team
  • Partners with team members and other functional areas within Adverum such as Regulatory, QA, Legal, CMC
  • Conducts co-monitoring and monitoring site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct
  • Help to develop and write SOPs for the Clinical Operations Department
  • Assist in the maintenance of central files including maintaining version and quality control of study documents submitted, assist in the file review of site clinical regulatory documentation to confirm completeness/track dates and reconciliation for audits, and preparing study files for archival.
  • Ensures tracking of essential documents are received and filed in the TMF, reviews site documents for accuracy; provides clinical team support with TMF filing and management.
  • Order and maintain ancillary clinical study supplies required for conduct of clinical trials, including copying, printing study documents, reference binders, and arrange shipping, tracking, accordingly.
  • Assist in the preparation and maintenance of Clinical Study Agreements and Confidentiality Agreements.
  • Assist with processing invoices from vendors Initiate request for investigator, site and vendor payments.
  • Enters and maintains study information in Clinical Trial Management System.
  • The Sr CTA may assist with vendor oversight and management, help identify issues in a timely manner and escalates to management as appropriate.
  • Conducts critical review and reconciliation of essential documents in TMF and independently manages TMF filing and management tasks.
  • Ensure timely completion of study tasks and update trial trackers on an on-going basis.
  • Audit of TMF.
  • Other duties as assigned.

About you:
  • Bachelor’s degree preferred. Preference in a health care or scientific discipline.
  • 1-4 years’ experience within clinical research or related experience in a pharmaceutical, biotechnology, CRO, healthcare setting, OR 6-8+ years’ experience within a Clinical Trials Assistant role
  • Strong attention to detail and excellent organization skills.
  • Strong interpersonal skills and communication skills (both written and oral) able to work effectively in a team/matrix environment.
  • Excellent verbal, written communication and presentation skills are required.
  • Experience using Office 365 (Word, Excel, Power Point) applications and Sharepoint
  • Experience with IXRS and EDC systems a plus.
  • Knowledge of clinical research operations, FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
  • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well defined instructions and procedures.
  • Ability to develop tools and processes that increase measured efficiencies of the project.
  • Experience in gene therapy and/or rare disease indications preferred.

About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation