Genprex
Clinical Operations

Clinical Research Associate (CRA I/II)

Remote - Dallas or Houston, Texas vicinity

COMPANY BACKGROUND

Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies to provide novel treatment approaches for patients with cancer and diabetes.

OVERVIEW

Based remotely, and reporting to the Director, Clinical Trials, the Clinical Research Associate (CRA I/II) will perform monitoring and site management activities for Genprex’s clinical trials to ensure the trials are conducted, recorded, and reported in accordance with the protocol, Genprex standard operating procedures (SOPs), ICH-GCP, and all applicable local and federal regulatory requirements.

JOB RESPONSIBILITIES
·       Aid in the study start-up activities including assisting with IRB and/or IBC submissions and preparation and assembly of study documents and materials
·       Perform all tasks associated with the preparation, conduct (remote and on-site) and follow-up of investigational site monitoring visits (selection, initiation, interim monitoring, and close-out) ensuring regulatory, ICH-GCP and protocol compliance
·       Serve as main point of contact for assigned sites
·       Manage site level activities
·       Ensure action items are addressed in a timely manner as per the Monitoring Plan
·       Identify and assist with the review of protocol deviations and data listings to ensure reliable quality data are obtained
·       Identify and manage or escalate trial related issues as appropriate
·       Provide trial training/re-training (i.e., protocol, system, process, etc.) to site staff
·       Maintain investigational site files within the study’s Trial Master File
·       Assist with preparation and conduct of investigator meetings, project team meetings and other study trainings as required.
·       Actively participate in applicable trial, department, company and/or vendor meetings
·       Review trial documents, forms, and plans
·       Provide training and mentoring to other CRAs
·       Perform other duties as assigned by the Director of Clinical Trials

QUALIFICATIONS

·       In-depth knowledge of clinical trial processes and activities as well as current regulatory and ICH-GCP guidelines
·       Ability to work independently and prioritize tasks and activities
·       Ability to interact with all levels of staff to coordinate and execute study activities both internally and externally
·       Strong organizational skills
·       Excellent written and verbal communication and presentation skills
·       CRA II must possess the ability to train/mentor other CRAs
·       Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
·       B.S./B.A. in nursing, biology, or a related life sciences discipline
·       1-2 years monitoring experience with pharmaceutical/biotech company or CRO/3-4 years for CRA II
·       Prior oncology experience preferred
·       Prior experience with CTMS, EMR, EDC, eTMF, IRS preferred
·       Must be able to travel up to 75% of the time domestically (fly and/or drive)
·       Proven ability to work effectively in a home-based/remote environment
·       Must have valid driver’s license

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