Full Job Description
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 an experienced and highly motivated professional to be an integral part of the Company's clinical operations team. The Lead CRA will support site management and study management activities for assigned clinical research studies. Responsibilities will include monitoring site compliance with protocols, serving as point of contact for investigational sites and applicable CRO personnel, and authoring study plans and other study documents or working procedures. Qualified candidates must possess comprehensive knowledge of clinical trial conduct in accordance with ICH/GCP and other related regulations or guidelines; excellent organizational and time management skills. Further, qualified candidates must be able to function independently, exercise good judgement, work in a fast-paced environment and travel (up to 20%).
Job Responsibilities will include:
Provide operational support to Clinical Trial Managers for assigned clinical studies.
Identify potential Investigators and clinical sites; and contribute to site selection and site activation.
Where applicable, effectively communicate with site staff to support study delivery; facilitate training or re-training of investigators and site staff.
Contribute to writing and review efforts for key study documents such as ICFs, CRFs, CRF Completion Guidelines, study plans, and study timelines.
Support development of Monitoring Plans and oversight of compliance to monitoring quality, including schedules and metrics.
Participate in CRO/vendor selection process for outsourced activities.
Supports set-up and maintenance of IRT/IVRS and central lab vendors.
Supports clinical trial supply delivery in collaboration with CRO and Supply Chain management.
Oversight and management of outsourced monitoring and site management activities by CROs to ensure successful conduct of the clinical trial and to ensure data integrity and quality, including identifying risks and implementing risk mitigation plans.
Review trip reports and follow-up letters as needed.
Provide input into CRF design process and implementation and setup of EDC systems.
Oversight of data cleaning activities in collaboration with the assigned CTM.
Proactively identify and collaborate with CRO to resolve monitoring and site management issues that arise during study conduct; manage escalation of site related issues.
Create, update, and implement appropriate innovative and best-in-class processes and SOP's related to clinical study development and execution and reporting, in collaboration with Clinical Development and Quality Assurance.
Perform monitoring or co-monitoring activities in compliance with ICH-GCP, MTEM SOPs, local laws & regulations, study protocol, Monitoring Plan and associated documents.
Ensure resolution of identified issues during clinical data and protocol deviation reviews in collaboration with Investigational sites and the clinical study team.
Travel up to 20%.
Bachelor of Sciences degree in Life Sciences, required.
5+ years of experience as CRA/Lead CRA in pharmaceutical industry or CRO with on-site monitoring responsibilities, preferably in oncology.
Comprehensive practical knowledge of clinical trial development, conduct, and reporting in accordance with ICH/GCP and other related regulations or guidelines.
Awareness of global regulatory and pharmacovigilance environments.
Excellent written and verbal communication skills in English is required.
Excellent organizational and time management skills.
Quality-oriented with excellent attention to detail.
Proficiency with all office suite tools (MS Word, Excel, PPT, Visio).
Ability to function independently and exercise good judgement.
Ability to work in a fast-paced environment.
Ability to drive and willingness to travel for study monitoring/co-monitoring (up to 20%).
This position has no supervisory responsibilities. This position reports to SVP of Clinical Operations.
Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.