Job Description
Role Objectives
As a Clinical Research Associate at at, you will be a part of a multi-disciplinary team that provides scientific, statistical, operations, and management support for commercially or federally funded clinical trials, by performing and coordinating all aspects of the clinical monitoring and site management process. You will be responsible for ensuring compliance with ICH Good Clinical Practices, FDA guidelines, local regulations, and Clinical Standard Operating Procedures. You'll conduct on-site or remote visits to assess site adherence to protocol and regulatory requirements, manage required documentation, and ensure patient and site data are audit-ready.
The Ideal Candidate:
- Team Player
- Detail Oriented
- Problem Solver
What You'll Do:
- Schedule and perform on-site or remote monitoring visit activities, inclusive of the following study visit types: Site Initiation Visit (SIV), Interim Monitoring Visit (IMV) / Routine Monitoring Visit (RMV), and Close Out Visit (COV)
- Contribute to the development of protocols, study tools, materials, and documentation for clinical sites.
- Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed.
- Review site-level investigational drug accountability and safety event documentation
- Review and verify patient files and records, informed consent, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies; provide training and/or initiate corrective action as required.
- Identify, document, track, and report site protocol deviations and violations as defined within the EAP Monitoring Plan
- Manage query resolution.
- Provide mentoring, training, and co-monitoring of junior team members
- Assist in the development of applicable Clinical Standard Operating Procedures
- Develop applicable document templates, including (but not limited to), Monitoring Plans, Monitoring Visit Reports, Confirmation Letters, Follow-Up Letters, and Query Logs
- Complete, review, and/or submit monitoring reports and query logs
- Address protocol or monitoring-related questions received from clinical sites for assigned programs
What You'll Need:
- Approximately 1-3 years of on-site and remote monitoring experience; The level/title will be determined as part of the interview process
- BA/BS, preferably in a life science, nursing, pharmacy or related field
- Clinical background preferred
- Broad range of therapeutic experience
- High organizational and logistics skills to ensure effective management of multiple sites and protocols within timeframes and on budget
- Superior written and verbal communication skills
- Computer literacy, including proficiency in MS Office and use of EDC systems
- Willingness to travel up to 80%
Job Tags
Permanent employment, Interim role, Local area, Remote job,