Strength Through Diversity
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Under the supervision of the Clinical Trial Monitoring Manager, will conduct monitoring tasks such as source verification of eligibility criteria, informed consent, or other specified study assessments.
- Ensures compliance with good clinical practice and regulatory guidelines by monitoring accurate, complete and timely data submission by clinical investigators via remote and in-person visits. Implements corrective action as necessary.
- Evaluates research data, protocol compliance and research file organization for clinical trials. Responsible for site monitoring, including review of source documentation, case report forms, electronic dates of entry and data reports for accuracy and timely submissions
- Will request and review source documentation related to protocol defined data collection from clinical sites. Will track source received and source monitored via the Electronic Data Capture System.
- Communicates results from contact reports and monitoring visits to appropriate staff.
- Assures adequate reporting of adverse events, deviations from protocols and patient status.
- Identifies areas requiring follow-up and improvement at each clinical study site. Recommends corrective action. Follows up on action items to ensure completion.
- Under the supervision of the Clinical Trial Monitoring Manager, will draft correspondence as needed to support monitoring related communications to clinical sites, including follow up to outstanding items from previous visits.
- Provide logistical support for monitoring visits including scheduling and document preparation as needed.
- Ensures that all study documentation is properly maintained.
- Participate in regular teleconferences, staff meetings, etc.
- Other duties as assigned.
- Bachelor's degree; Master's degree preferred
- Strong interpersonal communication skills, both written and verbal.
- Attention to detail and strong organizational skills are required.
- Ability to multi-task and thrive in a dynamic fast-paced environment.
- Ability to work independently within the scope of a team environment. Experience working in an academic environment with a concentration in Health Policy, Public Health, and Community Research preferred. required,
- Proficiency in MS Office software is highly desirable. Two years of clinical research experience preferred.