Clinical Research

• Prepare slides with academic activities for monthly staff meeting presentations
• Assist with monthly scientific Lunch & Learns, including speaker selection, slide preparation, meal ordering, conference room setup, and cleanup
• Attend clinical trial operations calls and take meeting minutes
• Participate in clinic shadowing opportunities with physician faculty
• Complete Trial Master File submissions and quality checks while learning TMF functions
• Assist with regulatory submissions and public trial registries for sponsored trials
• Assist with site regulatory documentation collection during study site start-up shadowing
• Learn Clinical Trial Management System functionality
• Complete Institutional Review Board submissions
• Learn budget functionality and role with the finance team
• Attend Site Endpoint Evaluation Visits and functional endpoint remote trainings
• Observe medical monitoring, narrative writing/shell building, DSMB, adjudication, and committee management activities
• Use clinicaltrials.gov and PubMed

Clinical Research Intern

• Perform all aspects of study site monitoring, including routine monitoring and close-out of clinical sites
• Maintain study files and conduct pre-study and initiation visits
• Liaise with vendors and manage sites according to project plans
• Ensure study staff receive proper materials and instructions
• Verify informed consent procedures and protocol compliance
• Monitor source documents and data for missing or implausible information
• Manage clinical study registries and undertake feasibility work
• Complete Serious Adverse Event reporting, narratives, and follow-up
• Perform CRF review and query generation and resolution using Fortrea or client data management systems
• Assist with training new employees through co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator
• Act as a local client contact when assigned
• Perform other duties assigned by management

Clinical Research Associate 2 – Oncology

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP), applicable prevailing laws, GCP, and the Sponsor's standards
• Manage operational aspects of clinical trial activities at assigned investigator sites from site activation through database lock
• Serve as primary point of contact for assigned investigator sites
• Facilitate information flow between study team members, vendors, and investigator sites
• Perform investigator site development, coaching, and training of site personnel
• Provide protocol training and address protocol-related questions
• Support investigator meetings, enrollment, site activation, recruitment initiatives, and recruitment issue resolution
• Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure
• Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
• Submit required reports, documentation, updates, and tracking, including TMF documentation, site reports, protocol deviations, recruitment, clinical supply management, study progress, and metrics
• Identify and resolve investigator site issues and develop corrective and preventative actions
• Resolve data queries and conduct investigator site close-out activities
• Oversee investigational product receipt, handling, accounting, storage, and destruction
• Support database release as needed
• Maintain understanding of the product, protocol, and therapy area
• Support patient safety, eligibility, and clinical guidance to investigators
• Drive Quality Event remediation and audit CAPA activities when applicable

Clinical Research Associate II/Sr. Clinical Research Associate

• Serve as the primary point of contact between investigational sites and the sponsor
• Conduct site selection, initiation, routine monitoring, and close-out visits
• Ensure site compliance with ICH-GCP, SOPs, and regulations
• Maintain documentation in CTMS and eTMF systems
• Support and track site staff training and compliance records
• Monitor patient safety and ensure timely AE/SAE/PQC reporting
• Support subject recruitment and retention efforts
• Oversee drug accountability and storage, return, or destruction
• Resolve data queries and drive timely, high-quality data entry
• Document site progress and escalate risks or issues to the clinical team
• Assist with site budgets and timely site payments as applicable
• Collaborate with CTAs, LTMs, CTMs, and other cross-functional partners

Clinical Research Associate – Cross Therapeutic Area

• Provide a high standard of care for participants in clinical trials
• Respond to emergency situations based upon clinical research standards
• Perform routine monitoring and close-out of clinical sites
• Maintain study files
• Conduct pre-study and initiation visits
• Liaise with vendors
• Manage study sites according to project plans
• Ensure study staff receive proper materials and instructions
• Verify informed consent procedures and protocol requirements comply with applicable regulations
• Monitor source documents and verify the integrity of CRF and other collected data
• Manage clinical registries and undertake feasibility work
• Complete Serious Adverse Event reporting, narratives, reports, and follow-up
• Perform CRF review and generate and resolve queries in data management systems
• Assist with training new employees through co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator
• Act as a local client contact when assigned
• Perform other duties assigned by management

Clinical Research jobs in Colorado

Clinical Research Intern

Clinical Research Associate 2 – Oncology

Clinical Research Associate II/Sr. Clinical Research Associate

Clinical Research Associate – Cross Therapeutic Area

Clinical Research Associate II, Phase I