Clinical Trial Associate

About Kalaris

Kalaris Therapeutics is a clinical stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases with major unmet medical needs.

Kalaris’ lead asset, TH103, was developed by Lasker Award winner, Dr. Napoleone Ferrara, a pioneer in the field of VEGF research, and the inventor of Lucentis and Avastin during his time at Genentech. TH103 is a novel, clinical stage anti-vascular endothelial growth factor (VEGF) drug, specifically engineered to achieve extended intraocular retention with enhanced VEGF inhibition in patients with exudative and/or neovascular retinal diseases.

In head-to-head preclinical studies, TH103 showed more anti-VEGF activity and longer duration of activity compared to aflibercept, the current market-leading anti-VEGF agent. In a Phase 1a single ascending dose trial, TH103 was generally well tolerated and showed a potent anti-VEGF effect on functional and anatomical outcomes at 1-month post-dosing. Single dose durability signals, including pharmacokinetic analysis and retreatment results, suggest that TH103 may offer extended treatment durability outcomes after a standard four-dose loading regimen. Kalaris is currently enrolling a Phase 1b/2 Multiple Ascending Dose trial of TH103 in patients with nAMD, to help assess the safety and efficacy of repeat TH103 administration and to inform dose selection for potential Phase 3 development.

Kalaris’ board of directors, management team and investors include co-founders, scientists and leaders and investors from companies that have played pivotal roles in developing retina therapeutics.

About nAMD

nAMD is a leading cause of blindness in the United States and Europe that affected an estimated 1.6 million adults in the United States in 2024. Over the past 20 years, anti-VEGF therapeutics have revolutionized the treatment of prevalent exudative and/or neovascular retinal diseases, which represented an estimated $15 billion global branded market in 2024. While clinical trials for these drugs have shown improvements in mean visual acuity, these results often are not reproduced in real-world settings. Many patients find the treatment burden to be challenging because it requires a demanding schedule of clinic visits and years of monitoring and treatments. This onerous treatment burden can lead to a lack of adherence to the frequent visit regimen and a decline in vision after initial gains.

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The Clinical Trial Associate (contract) provides operational, administrative, and logistical support to the Clinical Operations team across study start-up, conduct, and close-out. The CTA works with internal study teams, CROs, clinical sites, and external vendors to coordinate trial activities, maintain essential documentation, and support timely delivery of study milestones in compliance with ICH-GCP, applicable regulations, and company procedures.

The CTA supports sponsor oversight of outsourced activities and proactively tracks documentation, deliverables, communications, and action items. The position is suited to a detail-oriented, collaborative professional who can manage competing priorities in a fast-paced biotechnology environment.

Job Description and Specific Responsibilities

Clinical Trial Coordination & Study Execution

• Support clinical trial activities from study start-up through study conduct and close-out.
• Coordinate site feasibility, identification, activation, and ongoing study support activities, as assigned.
• Maintain study timelines, milestone trackers, site contact lists, enrollment updates, and operational status reports.
• Assist with preparation, review, distribution, and maintenance of study plans, manuals, informed consent forms, training materials, and other study documents.
• Coordinate shipment and tracking of study materials, ancillary supplies, and site equipment as applicable.

Trial Master File & Regulatory Documentation

• Coordinate collection, quality review, filing, reconciliation, and archival of essential documents in the electronic Trial Master File (eTMF).
• Perform routine TMF quality control checks and follow up with CROs and internal teams on missing or incomplete records.
• Assist with preparation and tracking of site regulatory documents and IRB/IEC submissions, as assigned.
• Support audit and inspection readiness, document retrieval, and follow-up on findings.

CRO, Vendor & Site Support

• Support day-to-day coordination with CRO teams, clinical sites, central laboratories, reading centers, IRBs, and other study vendors.
• Track vendor deliverables, issues, decisions, and action items; escalate delays and risks to Clinical Operations leadership.
• Assist with investigator meetings, site training, vendor meetings, and other study-related activities.
• Coordinate routine communications and follow-up to ensure timely completion of assigned study tasks.

Study Meetings & Reporting

• Schedule meetings, prepare agendas and minutes, and maintain action-item logs.
• Prepare study status summaries, presentations, trackers, and operational reports for internal stakeholders.
• Support review of clinical data listings and reconciliation activities when requested and under appropriate functional oversight.

Compliance & Process Improvement

• Perform assigned work in accordance with the protocol, ICH-GCP, FDA requirements, company SOPs, and study-specific plans.
• Complete required company and study-specific training on time.
• Contribute to development and improvement of Clinical Operations SOPs, templates, trackers, and work instructions.
• Collaborate with Clinical Operations, Data Management, Regulatory, Quality, Medical, and Clinical Supply colleagues.

Qualifications/Experience

• Bachelor’s degree in life sciences, healthcare, or a related discipline preferred; equivalent relevant experience may be considered.
• Typically 2–4 years of clinical research experience for a CTA II-level position; level may be adjusted based on qualifications.
• Experience supporting clinical trials in a biotechnology, pharmaceutical, CRO, or clinical research site environment preferred.
• Working knowledge of ICH-GCP, clinical trial documentation, and study start-up through close-out activities.
• Experience with eTMF, CTMS, EDC, and Microsoft Office applications preferred.
• Excellent organizational, communication, follow-through, and prioritization skills, with strong attention to detail.
• Ability to work independently on assigned tasks and collaboratively across internal and external teams.
• Experience coordinating CROs, vendors, and clinical sites is a plus; ophthalmology trial experience is desirable.

Additional Details

This role is based in Berkeley Heights, NJ, with an expectation of 3 days per week in-office. Occasional travel to study sites or investigator meetings may be required, depending on study needs.

Employment type: Contract (1099), period of up to 12 months

Compensation: The pay range for this contract position is $60 to $70 per hour.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States