Senior Clinical Research Associate (CRA)
Location: Australia (Remote, with travel requirements)
Job Type: Full-Time
Travel: As required for study start-up and site monitoring activities
Compensation: AUD $120,000 – $160,000 base salary (commensurate with experience)
Deep Intelligent Pharma is a cutting-edge, AI-enabled Contract Research Organization (CRO) transforming clinical trial execution through innovative technology and scientific excellence. We use anadvanced AI to replace large CRO teams for trial design, analysis, writing, translation, and regulatory documentation—all supervised by expert humans.
In February 2026, DIP raised a $170mm Series D round, led by Sequoia and SIG. Founded in 2017, DIP is pioneering a new, AI-native approach to clinical development. Our multi-agent platform performs scientific writing, data management, statistical reasoning, clinical programming, and regulatory compliance with exceptional speed and precision. Trusted by over 1,000 global pharmaceutical companies and biotechs, DIP is transforming how drugs are developed worldwide.
As we expand our clinical development portfolio, we are seeking a highly experienced Senior Clinical Research Associate to support one of our strategic client partnerships on the East Coast.
Position Summary
Deep Intelligent Pharma is seeking a Senior Clinical Research Associate (CRA) to serve as the dedicated monitoring lead for various Phase I clinical trials. This is a unique opportunity to be the sole CRA supporting a high-priority client program from inception through execution.
The ideal candidate will play a pivotal role during the critical study start-up phase, managing administrative workstreams, establishing site relationships, and building a solid foundation for successful trial execution. As the study progresses to active enrollment and monitoring, the CRA will serve as the primary field-based liaison, ensuring patient safety, regulatory compliance, data integrity, and quality standards in accordance with Good Clinical Practice (GCP) and FDA regulations.
This role offers the opportunity to work at the intersection of innovative AI-enabled clinical research technology and traditional monitoring excellence, providing direct client support in an immuno-oncology therapeutic area with significant clinical impact potential.
Key Responsibilities
Study Start-Up & Administrative Workstreams (Initial Phase)
* Lead comprehensive study start-up activities including site feasibility assessments, selection, and qualification
* Manage regulatory document collection, review, and maintenance for Investigator Site Files (ISF) and Trial Master File (TMF)
* Coordinate and conduct site initiation visits, ensuring thorough training of site personnel on protocol requirements, study procedures, and documentation standards
* Establish strong, collaborative relationships with Principal Investigators, study coordinators, and site research teams
* Support development and implementation of site-specific recruitment strategies
* Coordinate site budget negotiations and contract execution activities
* Utilize AI-enabled clinical trial management systems (CTMS) and electronic TMF (eTMF) platforms to ensure optimal documentation and workflow efficiency
* Collaborate closely with the client's internal study team and cross-functional partners
Ongoing Monitoring & Site Management
* Conduct routine monitoring visits (initiation, interim, close-out) in accordance with the monitoring plan, SOPs, and regulatory requirements
* Perform comprehensive source data verification (SDV) to ensure accuracy, completeness, and consistency of clinical data
* Review and verify informed consent documentation and processes for all enrolled participants
* Monitor compliance with study protocol, ICH-GCP guidelines, FDA regulations, and sponsor requirements
* Oversee accurate and timely reporting of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
* Ensure proper handling, storage, accountability, and documentation of investigational product
* Identify, document, and facilitate resolution of protocol deviations, data discrepancies, and quality issues; elevate to management as appropriate
* Provide ongoing training, guidance, and support to site personnel
* Track and manage site performance metrics including enrollment, data quality, and query resolution
* Leverage AI-powered analytics and risk-based monitoring tools to proactively identify potential issues and optimize site performance
* Prepare detailed monitoring visit reports and follow-up correspondence
* Support audit and inspection readiness activities
Client Partnership & Communication
* Serve as the primary point of contact for the client regarding site-level activities and field operations
* Participate in regular client and internal study team meetings, providing updates on site status, enrollment progress, and data quality
* Contribute clinical monitoring expertise and strategic insights to support client decision-making
* Maintain responsive, professional, and solution-oriented communication with all stakeholders
Required Qualifications
* Education: Bachelor's Degree in Life Sciences, Nursing, or related health/scientific discipline (or equivalent healthcare professional licensure such as RN)
* Experience:
* Minimum 4-5 years of clinical research monitoring experience in biotechnology, pharmaceutical, or CRO environments
* Minimum 2+ years of direct on-site monitoring experience
* Phase 1 clinical trial monitoring experience is required; experience with oncology, immunotherapy, or therapeutic vaccine trials strongly preferred
* Demonstrated experience leading or supporting study start-up activities from site selection through initiation
Technical Knowledge
* Comprehensive understanding of ICH-GCP guidelines, FDA regulations (21 CFR Parts 50, 56, 312), and clinical research best practices
* Strong knowledge of Phase 1 trial design elements including dose escalation, safety monitoring, and first-in-human considerations
* Familiarity with oncology/immunology therapeutic areas and related medical terminology highly desirable
* Proficiency with CTMS, eTMF, EDC systems, and clinical data management platforms
* Comfort working with AI-enabled monitoring tools and technology platforms (training will be provided)
* Exceptional organizational skills with ability to manage multiple priorities and work independently
* Strong attention to detail and commitment to data quality and patient safety
* Excellent written and verbal communication skills
* Proven ability to build and maintain effective relationships with sites and cross-functional teams
* Proactive problem-solving mindset with professional judgment and decision-making capabilities
* Ability to adapt in a dynamic, fast-paced environment and embrace innovative technology
* Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
Location & Travel
* Must be based in Australia
* Willingness and ability to travel domestically as required for site monitoring activities (anticipated to increase as study progresses)
Preferred Qualifications
* Background in immuno-oncology or vaccine clinical trials
* Previous experience as a sole or lead CRA on early-phase studies
* Knowledge of adaptive trial designs or risk-based monitoring approaches
* Experience supporting international pharmaceutical sponsors
* ACRP or SoCRA certification
What We Offer
* Competitive compensation package (AUD$120,000 – $160,000 base salary, based on experience and qualifications)
* Exposure to cutting-edge AI technology transforming clinical research
* Direct client partnership and visibility in a high-impact therapeutic program
* Collaborative, innovative, and supportive company culture
* Remote work flexibility with domestic traveling
#J-18808-Ljbffr