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.
Based remotely, and reporting to the Director, Clinical Trials, the Site Manager/Clinical Research Associate (SM/CRA) is responsible for all site management and monitoring activities for Genprex’s clinical trials. As a SM/CRA, you are expected to oversee and manage the progress of the investigator sites 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.
- Responsible for assigned sites at the time of study start-up activities as to provide support with IRB and/or IBC submissions, preparation and assembly of study documents and study 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 and oversee site level activities, including site performance with enrollment, data entry/cleaning, protocol adherence, regulatory requirements, timely safety reporting
- 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
- B.S./B.A. in nursing, biology, or a related life sciences discipline required
- 1-2 years of site management experience in a CRA role with a pharmaceutical/biotech company required
- 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
- Proficiency with Microsoft Office applications (Word, Excel, PowerPoint) required
- Preferred 2+ years monitoring experience
- 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