(Hybrid/Onsite; Consultant or Full Time)
Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines for different studies. Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites.
Your Contributions (include, but are not limited to):
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis, critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
- May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
- Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process.
- Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc.).
- Facilitates effective communication between investigative sites.
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), and FDA regulations
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology