Clinical Research Associate II

Aviceda Therapeutics is a private clinical-stage biotech company focused on the next generation of glyco-immune therapeutics that leverage its proprietary High-Affinity Ligands of Siglecs (HALOS ™) technology platform to address immune-mediated inflammatory disorders inflammatory diseases of the innate immune system including geographic atrophy (GA) from age-related macular degeneration (AMD), Immunology, Fibrosis, Cancer and Neurologic diseases, and others. Our lead asset derived from the platform, AVD104, is currently in a Phase 2b clinical trial in geographic atrophy.

Aviceda has assembled a world-class, cross-disciplinary team of recognized scientists, clinicians, and drug developers to tackle devastating ocular and systemic degenerative, fibrotic, and immuno-inflammatory diseases. Our primary offices and lab are based in Cambridge, Massachusetts, though we have subsidiary offices and labs in Belfast, Northern Ireland, and lab association agreements at the University of Georgia and in Utrecht, Netherlands.

Overview:

The Clinical Research Associate (CRA) will play a vital role in advancing Aviceda clinical studies contributing to the development of groundbreaking medical treatments and therapies. This person will be responsible for ensuring that clinical trials are conducted in compliance with regulatory guidelines and protocols, with the utmost focus on patient safety and data integrity. This position involves extensive collaboration with research teams, healthcare professionals, and regulatory authorities to facilitate the successful execution of our clinical trials.

Summary of Key Responsibilities:

Investigator Relations

·         Develop and maintain individual investigator relationships, guiding them on protocol data requirements and reviewing their progress on a regular basis

·         Ensure adherence to ICH-GCP and Regulations

·         Facilitate discussion on protocol requirements, enrollment, timelines, patient safety, and data quality

·         Liaise with study site staff to ensure timely and accurate CRF data

Vendor Contracts/Management

·         Monitor, evaluate and resolve all vendor issues

·         Drive timelines and provide guidance on all protocol, technology, and data questions

·         Train and assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements and timelines/milestones

·         Coordinate vendor data transfers

Site Support and Quality Assurance

·         May Conduct Site Evaluation, Site Initiation, Interim Monitoring and Close Out visits

·         Serve as first point of contact for site staff

·         Manage investigational product accountability and inventory throughout clinical study

·         Monitor study to ensure sites are in compliance with protocol, SOPs and regulations

·         Complete accurate monitoring reports and follow up letters in a timely manner

·         Review clinical study reports for regulatory submissions and follow up on assigned action items and queries

·         Ensure rights, safety and well-being of trial subjects are protected and the data is accurate and verifiable

·         Perform source data verification and ensure accuracy and completeness

·         Assist with Data Safety Monitoring Committee meetings

·         Assist with IP cold chain management, temperature excursion reporting, clarifications and complaints

·         Oversee site supply management including but not limited to injection needles, laboratory kits, masks, sham (placebo) materials, temperature monitoring devices, ophthalmological equipment, etc.

·         Review and Approve RTSM support requests

·         Review EDC and RTSM data for accuracy; assist sites with data corrections and reconciliation

·         Review of eTMF documents for accuracy

Other

·         Contribute to the development of Clinical Operations SOPs, procedural manuals, best practices, work instructions, tools and templates

·         Review and report site performance metrics to Aviceda leadership team members

Qualifications:

·         Bachelor's degree in a science-based discipline

·         Minimum 2 years of ophthalmology site management/operations experience

·         Experience with Trial Master File management according to the DIA reference model

·         Experience with EDC and RTSM systems

·         In depth knowledge and skill in applying applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

·         Excellent organizational and problem-solving skills

·         Effective time management skills

·         Strong written and verbal communication skills

·         Ability to travel up to 25%

Aviceda Therapeutics is an equal opportunity employer offering competitive cash and stock compensation, excellent employee benefits, and the opportunity for personal and professional growth in an outstanding and intellectually challenging environment.