- Provide oversight and administrative efforts to efficiently and effectively monitor the clinical trial process
- Verify and ensure that the rights and well-being of the human subjects enrolled in the clinical trials are protected and that the reported trial data are accurate, complete, and verifiable from source documents
- Ensure that the conduct of the trial is in compliance with protocols, current GCP, FDA CFR, and military regulations, along with other applicable Sponsor and regulatory requirements, requirements of host countries and other government regulations
- Lead the development, coordination, and implementation of monitoring and administrative strategies essential to the successful management of clinical trials research
- Conduct site pre-qualification and initiation visits; verifying that assigned research staff, facilities and investigational products have adequate qualifications and resources
- Conduct on-site clinical monitoring that includes: protocol training, document review, accurate data recording, verify patient data, ensuring adherence to the clinical protocol, site and Sponsor SOPs, investigational product accountability, verification of product shipping/storage conditions, etc.
- Monitor adverse events, concomitant medications, and inter-current illnesses and verify they are reported in accordance with the protocol on the Case Report Form (CRF)
- Conduct closeout site visits, including reviewing record retention requirements, investigational product reconciliation and securing and reviewing investigator’s final report.
- Work effectively as part of an Integrated Product Team (IPT) and act as the Sponsor’s liaison to resolve site related issues quickly and effectively
- Maintain written or email communication as well as telephone communication with the clinical sites
- Participate in reviewing protocols, amendments, investigator brochures, Informed Consent Forms (ICFs) and CRFs and facilitate Institutional Review Board (IRB) submission, queries, and approval
SKILLS AND EXPERIENCE:
- Advanced training in GCPs as well as significant experience in clinical trial monitoring, including paper and Electronic Data Capture (EDC) studies
- Travel 50-65% of the year
- Learn and speak foreign languages as appropriate
- Desires a minimum of a Bachelor’s degree in Science/Health-related field (i.e. Nursing, Medical Terminology, Biology or Biochemistry). A Master’s degree (within similar fields) is preferred and will equate to 1 – 3 years of experience.
- 7-10 years of experience in clinical trial monitoring, or appropriate experience transferred from related occupation such as RA Specialist, Quality Assurance Specialist, Site Coordinator
- Certification as a Certified Clinical Research Profession (CCRP) or Certified Clinical Research Associated (CCRA) is preferred.