Clinical Trial Associate

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Job description

Clinical Trial Associate

About the Company:

Dren Bio (the "Company") is a privately held, clinical stage biopharmaceutical company focused on developing therapeutic antibodies for the treatment of cancer, autoimmune and other serious diseases. The Company's management team and scientific advisors have profound expertise covering the discovery and development of specially engineered antibodies. Dren Bio's pipeline encompasses a multitude of programs from its two distinct, wholly-owned technologies. The Company's lead development candidate, DR-01, induces antibody-mediated killing of a specific cell type known to play a key role in various hematologic malignancies and autoimmune disorders. In addition to DR-01, the Company has launched multiple programs from its proprietary Targeted Myeloid Engager and Phagocytosis Platform, a bispecific antibody-based technology that offers a novel mechanism of action focused on selectively engaging myeloid cells (antigen presenting cells) for the targeted depletion of pathologic cells and other disease-causing agents.

Function:

Clinical

Level:

Associate

Location:

Foster City, CA (remote candidates may be considered)

Reporting Manager:

Senior Clinical Trial Manager

About the Opportunity:

The Clinical Trial Associate is responsible for providing administrative support to the Clinical Operations team under the supervision of assigned Clinical Trial Manager(s).

Role and Responsibilities:

• Supports the Clinical Operations team under the supervision of assigned ClinicalTrial Manager(s).

• Onboarding and training on SOPs, project-specific plans, study portals, and vendoroperations.

• 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.

• Contact clinical trial sites, CROs, vendors, and other collaborative partners asrequired. Acts as a point of contact between team members, vendors and study sitesto assist with study conduct escalating to the team as necessary.

• 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

• 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 years of experience in clinical research

• 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 escalate 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 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 $75,000 and $100,000 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.

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