ജോലി വിവരണം

About the Company

Avalo Therapeutics is a clinical-stage biotechnology organization devoted to developing IL-1β-centered therapies for immune-mediated inflammatory diseases. The company’s mission is aimed at addressing serious inflammatory conditions with substantial unmet medical need across global patient populations. Its work is grounded in teamwork, scientific commitment, and a patient-first approach, supported by experience across discovery, development, and regulatory approval pathways.

Role Overview

The Clinical Trial Associate will report to the Clin Ops Manager of Clinical Development Operations, or a designated delegate, and will contribute to the planning, execution, and completion of clinical studies. The role supports studies in line with company SOPs, ICH/GCP standards, regulatory expectations, timelines, budget, and quality requirements, while working closely with the Clinical Operations study management team.

This is a 6-month contract position with the possibility of being converted to a full-time role.

Key Responsibilities

Prepare and/or assess study plans, specifications, working documents, and operational tools.
Coordinate support for outsourced work handled by CROs and other external vendors.
Maintain study tracking in CTMS, including site activation, enrollment progress, patient status, and regulatory document oversight for site start-up and closeout.
Carry out operational tasks and help manage study metrics, trackers, and associated distribution.
Work with trial sites to build strong relationships and gather study-related materials and records.
Check documents for completeness, accuracy, and compliance with protocol and applicable regulations, then follow through on corrective actions when needed.
Help draft or review study documents such as informed consent forms, tools, templates, training materials, manuals, and study communications.
Handle meeting coordination tasks, including scheduling, room and equipment setup, material preparation, and attendance tracking.
With the Clinical Trial Manager, prepare agendas and produce, finalize, and circulate meeting minutes.
Perform quality control oversight for CRO deliverables, TMF content, monitoring visit reports, payment items, safety alert acknowledgments, ICFs, protocol amendments, and study closeout materials.
Develop effective working relationships with vendors and colleagues across functions.
Track payments made to vendors and study sites as required.
Support TMF quality review activities, including quarterly departmental QC for each study through collection, review, and submission of documents.

Qualifications and Experience

Bachelor’s degree in life sciences or a healthcare-related discipline.
2 to 5 years of relevant experience in a clinical site, CRO, sponsor, or clinical trial vendor environment, with sponsor-side experience preferred.
Working understanding of ICH GCP requirements and clinical protocols.
Proficiency with Smartsheet, Excel, Word, PowerPoint, SharePoint, Veeva, and Outlook.
Strong analytical thinking, troubleshooting ability, and a proactive sense of urgency.
Experience addressing complex site management challenges effectively.
High attention to detail when drafting, proofreading, prioritizing work, scheduling, and meeting deadlines.
Comfort working in a fast-moving environment with several competing priorities.
Excellent written and spoken communication skills.
Collaborative mindset, initiative, and willingness to improve how work is done.

Additional Details

The position requires 10% to 15% travel.

Agency Notice

Avalo uses a controlled process for outside recruiting support. The company does not accept unsolicited resumes from agencies or recruiters unless there is a written agreement or statement of work in place before submission. Resumes sent without that authorization, including those emailed to Avalo employees outside the approved process, are not eligible for placement fees and do not create any obligation on the company’s part.

Clinical Trial Associate

Where you'll work