Clinical Trials Administrator
Your mission
Job Description
The CTA will be involved in most activities in preparation for study set up, conduct and completing a Clinical Trial which usually includes:
- Arranging & participating in the organisation of Investigator Meetings & Study Team Meetings.
- Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.
- Prepare for the distribution of protocols, Investigator Brochures and CRFs, including keeping track of and re-ordering supplies.
- For studies allocated, with the Trial Master File Manager, set up and maintenance of the Trial Master Files (TMF) or electronic filing systems/ set up of the Investigator Site File (ISF).
- Managing and maintaining study documents & trial supplies e.g., Patient Information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites.
- Preparing essential clinical trial documentation, distributing, tracking, and filing of documents on return.
- Create & maintain study contact lists for team/sites/3rd parties/set up mail merges.
- Sending out Study Correspondence to all participating sites on an ongoing basis.
- Setting up of finance systems accurately, processing invoices & tracking payments for the trial for investigator payments.
- For studies allocated, with the Trial Master File Manager, co-ordinating archiving of study documentation.
- Assisting with CRF Design.
- Arranging translation of patient documents.
- Maintain understanding of Good Clinical Practice.
- Contribute to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documents.
Key Performance Indicators
- Ensuring the Trial Master Files are appropriately maintained.
- Ensuring tracking systems for trial related paperwork remain up to date.
Key Job Competencies
- Understanding of clinical trial processes and needs.
- Excellent transferrable skills.
- IT literacy, particularly in Word, Excel, and PowerPoint.
- Knowledge of ICH GCP.
Job Responsibilities
- 0 direct reports.
- Financial authority for submitting clinical team expenses and raising Purchase Orders on request.
Job background
- University degree or equivalent in health sciences, nursing or pharmacy or related field.
- Previous experience of working in Clinical Research or the Pharmaceutical Industry.
- Knowledge of the Industry/Clinical trial process and drug development.
- Experience of administrative support in a busy environment.
- Experience of using the DIA Trial Master File Reference Model.
About us
MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.
Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.
Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.