The Clinical Trial Associate (CTA) provides clinical trial coordination support to Project Teams for assigned clinical trial(s). This support includes tracking a wide range of key operational activities and maintenance of essential study documentation, including the electronic Trial Master File (eTMF). This position will work with internal team members and with external vendors and CROs.  The position will work cross-functionally and collaboratively to support clinical operations activities for a product’s development.

Primary Responsibilities:

• Assist the Clinical Trial Manager(s) (CTM) in the day-to-day operational activities of assigned trials to ensure study objectives and timelines are met with consistently high quality, in compliance with applicable SOPs and regulatory guidelines

·       Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems

·       Liaise with Clinical Sample Management for the tracking and coordination of biomarker testing with 3rd party labs/central labs

·       Collaborate with CRO/appropriate vendors to ensure timely training and access to necessary systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders (e.g., CRO and Clinical Site Staff)

·       Coordinate Project Team and departmental meetings, including associated documentation

·       Assist with vendor / clinical site agreements, budgets and reconciliation / tracking of purchase orders and invoices for assigned trials

·       Develop and maintain strong, collaborative relationships with key stakeholders within the organization, its CROs and vendors, and clinical sites

Qualifications:

·       BS in a science-based discipline preferred with least 2 years of experience in a clinical research environment

·       Basic understanding of drug development, including knowledge of ICH GCP guidelines to ensure the appropriate conduct of clinical studies

·       Self-motivated and comfortable with shifting priorities and change in a small company environment

·       Good verbal and written communication skills

·       Good time management skills

·       Excellent organizational skills and attention to detail

·       Willingness to learn, able to take (and apply) direction and ability to manage multiple, parallel tasks