Sr. Clinical Research Associate
We are a gene therapy company changing lives with every genetic advancement.
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that cure genetic diseases has never wavered.
As the only end-to-end gene therapy company in the industry, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly owned, independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy Platform. Our global headquarters are in Research Triangle Park, North Carolina, a thriving biotechnology hub, and we maintain additional research and development operations in Scotland and France and gene therapy manufacturing in Spain.
We have an opportunity for a Sr. Clinical Research Associate to join the AskBio team in our Columbus, Ohio location and be part of our continued success!
About the role
The Senior CRA will join clinical operations as part of the core study teams working together with the clinical trial managers to oversee site management and monitoring activities.
Responsibilities & Accountabilities
- Assess clinical trial site performance, adequacy of monitoring activities and proactively identify and communicate site management and monitoring risks to the clinical team
- Establish and maintain effective project/clinical site communications, develop and manage site management and monitoring plans, proactively identify gaps in processes/plans and assessment for process improvements and efficiencies
- Conduct pre-study, initiation, monitoring and close-out visits and prepare monitoring visit reports and letters
- Assist in resolving any issues to ensure compliance with site file audits and assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits
- Verify electronic case report form data against written and electronic source documents
- Verify accountability, stability, and storage conditions of clinical trial materials
- Ensure the investigator site file remains inspection ready including review, collection and maintenance of the sponsor trial master file
- Review the quality and integrity of the clinical data through in-house review of electronic case report form data and on-site source verification and perform serious adverse event review and reconciliation
- Facilitate early identification of risk/issue(s) occurring during study conduct and be responsible for identification of risk alerts, timely escalation of risk/issue(s) to relevant stakeholders (e.g. study manager), and track risk/issue(s) until resolution
- BS or a RN in a related field or an equivalent combination of education, training, and experience (5+ years)
- Knowledge of Good Clinical Practice and International Council for Harmonization Guidelines and other applicable regulatory requirements
- Strong knowledge of electronic systems, e.g. electronic case report form, electronic Trial File Master, and Clinical Trial Management System
- CNS and/or gene therapy experience
- Proven ability of strong decision making and problem-solving skills
- Experience in risk-based and central monitoring
Live an AskLife™
We offer a competitive total rewards package. Are you our next great discovery?