Position Overview
Position Responsibilities
- Ensure that monitoring activities (remote and on-site) are completed in accordance with company/client SOPs and Clinical Monitoring Plan.
- Conduct on-site and remote study monitoring and site management.
- Assist project manager with clinical study planning and management, as required.
- Assist Clinical Trial Manager with drafting protocol-specific manuals, plans, and documents as needed.
- Develop and maintain positive relationships both internal and external to project, including clients, team members, and site personnel (PIs, Study coordinators, etc.).
- Assist in the identification and recruitment of potential investigators and study sites.
- Verify site qualifications and capabilities to conduct clinical studies.
- Assist Clinical Trial Manager and In-House CRA with ensuring that Trial Master File is accurate and complete throughout the lifecycle of the project.
- Prepare and conduct site training for assigned clinical trials.
- Assist with site audits and site quality management activities as needed.
- Maintain current knowledge of GCP and FDA guidance as it relates to Clinical Research, as well as current developments in the assigned therapeutic areas.
Qualifications
- Bachelor's degree (B.A./B.S.) in life sciences, healthcare or a related scientific discipline or Registered Nurse/Allied Health Professional with Clinical Research experience.
- 2+ years of Clinical Research experience required
- Minimum of 1 year of direct, on-site clinical trial monitoring experience required
- Medical device experience is a plus
- Knowledge of ICH guidelines for GCP
- Knowledge of clinical monitoring procedures and best practices
- Experience using Electronic Data Capture (EDC) and clinical trial management systems
- Strong written and verbal communication and presentation skills
- Strong research, analytical, critical-thinking, and problem-solving skills
- Proficiency with MS Office Suite (Outlook, Word, Ppt, Excel) and internet applications
- Ability to read, write, speak, and understand English
Special Requirements
- Travel (75%) required for this position