(Hybrid/Onsite)
Supports the operational activities for planning, initiation, conduct and close out of assigned Clinical Studies. Manages essential document collection and Institutional Review Board (IRB) and Ethics Committee (IEC) submission and approval procedures from start up through closeout for assigned trials. Collaborates with clinical research colleagues within EpicentRx and at Investigator sites to conduct clinical trials adhering to Good Clinical Practice (GCP) and ensuring accurate data, subject safety and impeccable documentation.
Your Contributions (include, but are not limited to):
- Working with the Clinical Trial Managers (CTMs) and Regulatory Manager, helps ensure clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies
- Serves as a team member for of assigned clinical studies
- Provides administrative support, ensuring regulatory essential documents are filed, monitoring reports are collected, and tracking of study site activity for assigned studies
- Participates in study team meetings and tracks study issues. Under direction of the CTM, creates study timelines in accordance with corporate goals. Helps with recruitment efforts
- Participates in operational functions of the study including updating monitoring plans, documenting on-site monitoring guidelines, forms, tools and may participate in onsite monitoring and co-monitoring visits, as necessary
- Works collaboratively within clinical operations in documenting EpicentRx standard practices across clinical programs
- Develops relationships with investigator sites, IRBs/IECs, and CROs to ensure trial needs and requirements are met
Requirements:
- BS/BA in Scientific field or equivalent and 2+ years of clinical trials or operations experience, CRO/Vendor Management exposure is preferred. Participation in monitoring clinical trials or related experience preferred OR
- Master’s degree in Scientific field or equivalent and Some experience as noted above
- Working knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive
- Working knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out
- Some trial management protocol and process knowledge
- General understanding of Clinical Research industry and the relevant environments in which it operates
- Ability to plan activities and works well under changing circumstances; manages time effectively