Clinical Trial Associate / Senior Clinical Trial Associate

Dren Bio, Inc.; San Carlos, Northern (CA, KY); Hybrid; USD 80,000 - 110,000; Full time

Job summary

Dren Bio, a clinical-stage biopharmaceutical company, is seeking a Clinical Trial Associate / Senior Clinical Trial Associate to support the Clinical Operations team in San Carlos, CA. Remote candidates may be considered.

The role involves onboarding, study tracking, site activation, TMF maintenance, and vendor coordination. Ideal candidates have 1–2 years in clinical research and strong communication skills.

Qualifications

• Bachelor's degree preferred; high school diploma or equivalent required.
• 1-2 years of experience in clinical research, oncology preferred.
• Excellent verbal and written communication skills; interpersonal skills required.

Responsibilities

• Provides administrative support to Clinical Operations under supervision.
• Onboard and train on SOPs, CTA responsibilities, study protocol and project plans.
• Create and maintain tracking tools for study operations and performance metrics.
• Assist with site start-up activities and vendor management.
• Maintain the Trial Master File (TMF) and participate in meetings.
• Communicate site start-up status to the team; escalate issues when needed.
• Travel up to 10% may be required.

Skills

Microsoft Office

EDC

IRT

TMF

CTMS

Communication skills

Detail-oriented

Education

Bachelor's degree preferred

Tools

Microsoft Office Suite

Adobe Acrobat

Job description

Clinical Trial Associate / Senior Clinical Trial Associate

About the Company:

Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering thediscovery and development of first-in-class antibody therapeutics for the treatment ofcancer, autoimmune disorders, and other serious diseases. Leveraging our wholly ownedtechnologies, we have built a robust R&D pipeline, including two clinical-stage candidatescurrently being evaluated across multiple ongoing clinical studies. Our lead clinicalcandidate, dibotatug, is designed to induce antibody-mediated killing of a specific celltype implicated in a range of oncology and autoimmune indications. In addition, we havelaunched multiple programs from our proprietary Targeted Myeloid Engager and PhagocytosisPlatform, a multispecific antibody-based technology engineered to selectively engage a novelphagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeteddepletion of pathologic cells and other disease-causing agents. Data generated using theplatform support its broad therapeutic potential, including initial programs focused ononcology, immunology, and neurology. Importantly, multispecific antibodies generated fromthe platform are specially designed to activate phagocytic mechanisms only in the presenceof disease targets, potentially offering a superior safety profile compared to otherimmunomodulatory therapies. For more information, please visit our website atwww.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 providingadministrative support to the Clinical Operations team under the supervision of assignedClinical 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 QualificationRequirements:

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 SkillRequirements:

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 areasand can effectively interact with individuals at all levels of the organization anddevelop cohesive relationships with the team

Ability to manage multiple competing priorities, being able to rapidly gather,assimilate and disseminate information on critical project components andmilestones, 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 isembodied in the Company’s total rewards program, which includes competitive cashcompensation, equity incentive awards, and employer sponsored benefit offerings. The basepay range for this position at commencement of employment is expected to be between $80,000and $110,000 per year. At Dren Bio, pay ranges are determined by role, level(s), andlocation. The range displayed in this job posting reflects the minimum and maximum new hirepay for candidates located across all United States job markets. Within the range,individual pay will be determined by work location and additional factors, includingjob-related skills, experience, and relevant education or training. During the hiringprocess, Dren Bio’s Human Resources department can share more about the specific pay rangebased on the market location of the candidate.

Employment Practices:

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