Sr Clinical Research Coordinator
- Posted: over a month ago
We are seeking a full-time Sr Clinical Research Associate to join our Baltimore, MD Research team!
The Sr CRA will perform all the tasks related to clinical monitoring and ensuring clinical studies are being performed in accordance with the Sponsor protocol and GCP ICH guidelines. The Sr CRA will act as the sites' main source of information and performance manager. The Sr CRA will provide support, training, and study procedure knowledge to the sites and study teams to ensure successful conduct and completion of the sponsor's study.
- Verify that the investigator(s) and study personnel are conducting the study according to the protocol, "Good Clinical Practices", and regulatory requirements to ensure protection and ethical treatment of human subjects.
- Perform all required monitoring visits as per the monitoring plan to include: Pre-Study Visit (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close Out Visit (COV).
- Ensure identification and reporting of safety issues, when applicable, from research site staff to the sponsor and the IRB/IEC.
- Perform monitoring activities per the monitoring plan (e.g. verification of source documents and eCRF/CRFs, site communications, follow up on data anomalies, etc.).
- Review accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools).
- Ensure accountability of Investigational Product and related supplies are performed, when appropriate.
- Ensure the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness.
- Responsible for creating, generating and providing confirmation letters and follow up letter to the Principal Investigator and site for each visit.
- Follow study protocol and procedures while ensuring the quality completion of the clinical study.
- Ensure information is communicated and conveyed to the study team as it pertains to their assigned sites and studies.
- Escalate any site issue to the Clinical Trial Manager and/or study team, as needed.
- Ensure that training and applicable Sponsor information and/or materials are completed for their position.
- Produce monitoring reports in accordance with the monitoring plan and required submission timelines.
- Ensure compliance with quality standards (SOPs, ICH, GCP etc.).
- Develop in-depth knowledge in relevant indications and clinical study methodology.
- BA degree or RN or higher, preferentially in sciences/medical sciences, or equivalent experience.
- At least 5 years of clinical monitoring experience.
- At least 8 years of experience in the pharmaceutical industry or clinical research site-based experience.
- Knowledge of ICH GCP guidelines.
- System experience preferred: (i.e. CTMS, EDC, eTMF, etc.)
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