The Clinical Trial Associate (CTA) will be responsible for multiple tasks that support AVROBIO’s clinical trials. The CTA will play a key role and will work closely with the clinical study team to support activities required for the execution and ongoing conduct of investigational clinical trials in compliance with SOPs, Regulatory Authorities, and ICF/GCP guidelines.
- Responsible for coordination, tracking, and management of logistics in support of clinical trials.
- Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply.
- Reports study metrics and other critical information to the Clinical Operations Lead (COL)/Clinical Trial Manager (CTM) using study trackers, data forms, and reports.
- Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines, etc.
- Responsible for set-up, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files. Coordinates TMF transfer with CROs.
- Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific study requests and issues.
- Works with CRO to collect and review essential regulatory documents prior to site initiation/study drug release.
- Assists COL/CTM in review of study plans.
- Assists COL/CTM in review and approval of informed consent templates.
- Participates in user acceptance testing (UAT) for EDC.
- Manages and coordinates logistics for clinical and non-clinical supplies.
- Responsible for agendas and meeting minutes for clinical study team meetings.
- Manages logistics and assists with the coordination of investigator meetings, CRO kick-off meetings, and vendor meetings along with COL/CTM and external meeting planners.
- Responsible for routing, tracking, and coordinating site and CRO/vendor Confidential Disclosure Agreements (CDAs), contracts and change orders with Associate Director Clinical Operations, legal, and finance departments.
- Assists with facilitating site advertisement review and approval.
- Bachelor’s degree or equivalent degree in a scientific dicipline, RN, or related field with 1-3 years of experience in the pharmaceutical, biotechnology, CRO and/or healthcare setting.
- Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures.
- Working knowledge of regulatory documents and TMF maintenance.
- Understanding in relevant clinical operations activities.
- Ability to exercise judgment within generally defined practices and policies that lead to methods or processes for obtaining results under supervision.
- Basic knowledge and understanding of ICH/GCP guidelines and FDA regulations required.
- Working knowledge of TMF maintenance and management of essential documents.
- Solid interpersonal, written and verbal communication skills across study team including study management.
- Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, and organization tools.
- Attention to detail and accuracy in work.
- Effective time management and organization skills.
- Ability to multi-task under limited direction and on own initiative.
- Performs other work-related duties as assigned.
Other Job Requirements:
- Available for up to 10% domestic and/or international travel.
- Responsible for special projects supporting operations/departmental initiatives such as ClinicalTrials.gov, SOPs, GCP, process enhancements, outsourcing, Sunshine Act, systems implementation, training, etc.
- Maintains knowledge of therapeutic area(s) as well as changes to the ICF/GCP guidelines.
- Supports department initiatives and process improvements.
To apply, email your resume to: email@example.com
AVROBIO, Inc is an EEO employer
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON