Clinical Trial Associate / Senior Clinical Trial Associate

BioSpace; San Carlos (CA); Hybrid; USD 80,000 - 110,000; Full time

Job summary

Dren Bio in San Carlos, CA, is seeking a Clinical Trial Associate / Senior Clinical Trial Associate to provide administrative support to the Clinical Operations team. You will work under the supervision of the Clinical Trial Manager and Lead CTA to support study start-up, regulatory documents, and site coordination.

The role requires 1–2 years of clinical research experience, strong communication skills, and proficiency with EDC/CTMS tools.

Qualifications

• 1–2 years of clinical research experience, preferably in oncology.
• Proficiency in Microsoft Office and Adobe Acrobat.
• Experience with EDC, IRT, TMF, and CTMS systems.
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing clinical trial conduct.
• Knowledge of drug development process.

Responsibilities

• Provides administrative support to the Clinical Operations team under supervision of the Clinical Trial Manager(s) and Lead CTA.
• Onboards and trains on SOPs, CTA responsibilities, study protocol, and project-specific plans.
• Creates and maintains tracking tools for study operations and performance metrics.
• Assists with creating, updating, and maintaining site-facing study documents and tools.
• Manages site start-up activities from CDA to activation with site staff and CRAs to meet enrollment goals.
• Communicates site start-up status to the team during meetings.
• Maintains TMF and participates in meetings with internal and external partners.

Skills

Clinical research experience

Communication skills

MS Office proficiency

Team collaboration

Education

Bachelor's degree preferred

High school diploma or equivalent required

Tools

EDC

IRT

TMF

CTMS

Job description

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 of cancer, autoimmune disorders, and other serious diseases. Leveraging our wholly owned technologies, we have built a robust R&D pipeline, including two clinical-stage candidates currently being evaluated across multiple ongoing clinical studies. Our lead clinical candidate, dibotatug, is designed to induce antibody-mediated killing of a specific cell type 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 novel phagocytic 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 from the platform are specially designed to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile compared to other immunomodulatory therapies. For more information, please visit our website at www.drenbio.com.

Function

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.

Role And Responsibilities

• Supports the Clinical Operations team under the supervision of assigned ClinicalTrial Manager(s) and Lead Clinical Trial Associate.
• Onboarding and training on SOPs, CTA responsibilities, study protocol andproject-specific plans, study portals, and vendor operations.
• Creation and maintenance of tracking tools for clinical study operations andperformance 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, studydocument versioning, etc.)
• Assist with creation, updates, and maintenance of site-facing study documents andstudy tools (e.g., manuals, regulatory templates, reporting forms, trainingmaterials, cheat sheets, etc.)
• Assist with collecting and tracking study and site metrics and maintaining studytrackers. 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 throughsite 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 andexternal partners.
• Assist with vendor management
• Assist with developing strong site relationships
• Contact clinical trial sites, CROs, vendors, and other collaborative partners asrequired to support and track progress of deliverables and escalating to the team asnecessary
• 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 inoncology.
• Excellent verbal, written communication skills, and interpersonal skills arerequired.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint) and Adobe Acrobat.
• Experience with EDC, IRT, TMF, and CTMS systems.
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing clinicaltrial conduct.
• Knowledge of drug development process

Core Competencies, Knowledge And Skill Requirements

• A highly motivated self-starter
• Detail oriented with strong organizational and time management skills
• Independent thinker with ability to work independently as well as in a team
• Ability to use resources to problem solve, uses judgement to elevate as necessary
• Ability to work under pressure and timeline constraints
• Manages change with a positive approach to self, team and the business
• A mature and self-assured team player who will work well with other functional areas and can effectively interact with individuals at all levels of the organization and develop cohesive relationships with the team
• Ability to manage multiple competing priorities, being able to rapidly gather, assimilate and disseminate information on critical project components and milestones, and to translate to internal or external staff assigned to projects
• Attention to detail with ability to manage technical/scientific aspects
• Ability to work in an environment of remote collaborators
• Patient centric philosophy towards research

Salaries, Benefits And Other Employee Perks

Dren Bio strongly believes in investing in, and rewarding, its employees. This philosophy is embodied in the Company’s total rewards program, which includes competitive cash compensation, equity incentive awards, and employer sponsored benefit offerings. The base pay range for this position at commencement of employment is expected to be between $80,000 and $110,000 per year. At Dren Bio, pay ranges are determined by role, level(s), and location. The range displayed in this job posting reflects the minimum and maximum new hire pay for candidates located across all United States job markets. Within the range, individual pay will be determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, Dren Bio’s Human Resources department can share more about the specific pay range based on the market location of the candidate.

Employment Practices

Dren Bio is an equal opportunity employer. Employment decisions are based on merit and business needs. Dren Bio will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law.