Clinical Trial Associate/Senior Clinical Trial 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 Clinical Trial Associate (CTA) or Sr CTA to join the AskBio team in our Durham, North Carolina location and be part of our continued success! This position can be remote.
About the Role
Provides support for the creation and maintenance of paper and/or electronic clinical trial records including the Trial Master File (TMF) with a focus on maintaining inspection readiness throughout the lifecycle of an individual clinical trial or a clinical development program. The CTA is an integral part of the study/trial team in assuring that all clinical trial paperwork is handled appropriately and that assigned TMFs are complete, accurate, and timely.
Responsibilities and Accountabilities
- Supports the clinical trial manager(s) and overall study team for all phases of study conduct (feasibility, planning and start up, conduct/maintenance, and closeout).
- Assists with maintaining study status updates on agreed cadence (examples of activities tracked include IRB approvals, regulatory document collection, patient enrollment, monitoring status, etc.)
- Provides support for inspection readiness by formatting, proofreading documents and contributing to the establishment, maintenance and quality control of the TMF (maintained internally or by CROs)
- Assists clinical trial managers (CTM) with preparation, handling, distribution and tracking of clinical trial supplies and other study supplies
- Prepares and maintains investigator information tracker for clinical trial operations, working with in house or vendor CRAs and CTMs
- Supports compilation of documentation for CSR appendices based on clinical trial protocol and clinical study report (CSR) requirements
- Assists in the development of the structure of TMF and filing system and supports study team in maintaining up to date study documents; assists with or independently conducts Quality Control review of in house or vendor TMF(s)
- Coordinates timely resolution of document issues with the documents from study sites, data management centers, and other trial collaborators
- Generates regulatory compliant Certified Copies when/as needed
- Creates Metrics Reports to assist with trial oversight and to demonstrate quality and completeness of the TMF as well as other study documents
- Assists with planning, organization and conduct of external meetings such as Investigator Meetings
- Reviews regulatory documents to ensure completeness in accordance with Sponsor requirements, ICH/GCPs, CFR, EMA, MHRA and other health authority requirements/regulations.
- Organizes and provides oversight of study contracts, budget documents, billing and invoices – supports study team to process all study financial documents to ensure timely processing, payment, and tracking; assists with budget reconciliation
- BS degree preferred or AS + 3 years’ experience
- Minimum 3 years’ experience in clinical trial support
- Familiarity and experience with clinical trial Records Management and TMF requirements and practices
- Demonstrated organizational skills and attention to detail
- Ability to work independently and rearrange work assignments as priorities/business needs change; manage multiple assignments with competing and aggressive timelines
- Proficient computer skills (e.g. Microsoft WORD, EXCEL, PowerPoint
- Prior experience with setting up and managing study and/or program level tracking
- Prior experience processing contracts and resultant invoices for payment and tracking
- Significant knowledge of the drug development process, relevant regulatory requirements for drug approval and documentation required for Inspection Readiness
- Demonstrated ability to build successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise
- Excellent verbal and written communications skills; able to communicate proactively and effectively
Live an “AskLife™
We offer a competitive total rewards package. Are you our next great discovery?