Clinical Trial Associate/Senior Clinical Trial Associate
Listed on 2026-09-21
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Healthcare
Clinical Research
Location: Northern
Clinical Trial Associate / Senior Clinical Trial Associate
About the Company:
Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of first-in-class antibody therapeutics for the treatment ofcancer, autoimmune disorders, and other serious diseases. Leveraging our wholly owned technologies, we have built a robust R&D pipeline, including two clinical-stage candidatescurrently being evaluated across multiple ongoing clinical studies. Our lead clinical candidate, dibotatug, is designed to induce antibody-mediated killing of a specific celltype implicated in a range of oncology and autoimmune indications.
In addition, we have launched multiple programs from our proprietary Targeted Myeloid Engager and Phagocytosis Platform, a multispecific antibody-based technology engineered to selectively engage a novelphagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeted depletion of pathologic cells and other disease-causing agents. Data generated using the platform support its broad therapeutic potential, including initial programs focused on oncology, immunology, and neurology.
Importantly, multispecific antibodies generated fromthe platform are specially designed to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile compared to otherimmunomodulatory therapies. For more information, please visit our website
Clinical Operations
Level:Associate
Location:San Carlos, CA (Remote candidates may be considered)
Reporting Manager:Clinical Trial Manager
About the Opportunity:The Clinical Trial Associate / Senior Clinical Trial Associate is responsible for providing administrative support to the Clinical Operations team under the supervision of assigned
Clinical Trial Manager(s) and Lead Clinical Trial Associate.
Supports the Clinical Operations team under the supervision of assigned Clinical Trial Manager(s) and Lead Clinical Trial Associate.
Onboarding and training on SOPs, CTA responsibilities, study protocol and project-specific plans, study portals, and vendor operations.
Creation and maintenance of tracking tools for clinical study operations and performance metrics (e.g., start-up requirements, regulatory documents, IRBsubmissions and approvals, site contact information, site user system accounts andaccess, central imaging requirements and submissions, EDC metrics, lab supplies,central lab samples, enrollment, subject visit and status, FAQ, decision, study document versioning, etc.)
Assist with creation, updates, and maintenance of site-facing study documents andstudy tools (e.g., manuals, regulatory templates, reporting forms, training materials, cheat sheets, etc.)
Assist with collecting and tracking study and site metrics and maintaining study trackers. Utilize information collected to report to team
Update and maintain study document portal and site access to study document folderand materials.
Manage all site start-up activities from CDA and feasibility questionnaire through site activation by working directly with site staff and Dren Bio CRAs to support anddrive start-up and enrollment goals and timelines.
Communicate and present site start-up status and updates to Clinical Operations teamand other relevant functional groups during study team meetings.
Perform administrative tasks to support clinical project
Works with the team to maintain the Trial Master File (TMF) and ensure it is current.
Participates in meetings and conference calls with internal project teams and external partners.
Assist with vendor management
Assist with developing strong site relationships
Contact clinical trial sites, CROs, vendors, and other collaborative partners as required to support and track progress of deliverables and escalating to the team as necessary
Demonstrates interest in improving existing processes, communicating potential areasof inefficiencies to team members and contributes to or initiates process change
Up to 10% travel may be required.
Education, Experience and Qualification Requirements:Bachelor's degree preferred, high school diploma or equivalent required
Must have at least 1-2 years of experience in clinical research, preferably in oncology.
Excellent verbal, written communication skills, and interpersonal skills are required.
Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint) and Adobe Acrobat.
Experience with EDC, IRT, TMF, and CTMS systems.
Knowledge of FDA…
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