Clinical Trial Assistant
Molecular Templates (MTEM) is a clinical stage biopharmaceutical company focused on the development of a next generation immunotoxin platform technology called Engineered Toxin Bodies (ETB) in oncology. MTEM's lead program, MT-3724, is in clinical development for non-Hodgkin's lymphoma and additional pipeline drug candidates are being advanced toward clinical development for a variety of cancers. For more information, please visit MTEM's website at www.mtem.com.
Molecular Templates is seeking a highly-motivated and skilled professional to assist the Clinical Operations team. The Clinical Trial Assistant will provide support through maintenance of clinical trial studies. This includes establishing and maintaining the trial master file structure for all ongoing studies, providing coordination of supplies and inventory, coordinating meetings and preparing materials and ongoing general administrative support. This position requires excellent technical, analytical, time management and organizational skills, along with adherence to written and verbal instructions and accurate and timely completion of documentation. This position requires excellent organizational, time management and multi-tasking skills, along with the ability to follow standard operating procedures and manage competing priorities.
- Provide support to the clinical department to assist with execution and maintenance of clinical studies, including but not limited to: Creating and maintaining the trial master file, tracking incoming and outgoing clinical and regulatory documentation and updates for CROs, other departments, sites, partnership collaborations, and vendors, as applicable; maintaining study documents, binders, manuals, and supplies to ensure adequate inventory for Clinical Operations and clinical sites; ensuring assigned study compliance with company SOPs and guidelines; tracking study-specific metrics as assigned by the study CRA or CTM; reviewing monitoring visit reports and follow up letters in accordance with assigned study monitoring plan(s), providing feedback to CRAs/CROs, as necessary.
- Coordinate Clinical Operations team meetings and preparing materials for investigator meetings, partner meetings, scientific meetings, including complex coordination of multiple stakeholders, preparation and distribution of meeting minutes and poster preparation and printing for conferences.
- Deliver general administrative support, such as formatting documents and slide. presentations, drafting and revising departmental SOPs, collaborating with departmental members to identify Clinical Operations process and resource needs, assisting other departments (e.g. QA, regulatory affairs) as needed with the Document Control System and regulatory submissions, assisting with travel coordination and support budget tracking.
- Bachelor in Life Sciences or equivalent.
- Minimum of one (1) year of experience of clinical research in pharmaceutical industry, CRO or clinical research site, plus direct experience creating and maintaining trial master file documents, and preparation and submission of documentation to ethics, regulatory, or other relevant authorities related to clinical trial conduct
- Comprehensive practical knowledge of the clinical trial conduct and reporting in accordance with ICH/GCP and other related regulations or guidelines.
- Excellent written and verbal communication skills
- Excellent organizational, project management and time management skills
- Excellent attention to detail and accuracy
- Proficiency with all office suite tools (MS Word, Excel, PPT, Visio)
- Ability to work with cross-functional study teams and coordinate collaboration with investigative centers, clinical staff and CROs
- Ability to function under minimal supervision and exercise good judgement
- Ability to work in a fast-paced, high-growth environment
This position has no supervisory responsibilities. This position will report to VP, Clinical Operations.
Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.