Senior Clinical Research Associate (Sr. CRA)
The Steely Group
Chicago, IL
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JOB DETAILS
LOCATION
Chicago, IL
POSTED
22 days ago
Responsibilities:
- Serves as a CRA to conduct and document qualification, study initiation, interim monitoring, and close-out visits at investigator sites in accordance with the monitoring plan.
- Monitors data, on site and/or remotely (as needed), with a focus on participant safety, data integrity and regulatory compliance. Ensures the validity, correctness, and completeness of clinical data.
- Ensures data accuracy, accountability and documentation through review of case report forms, source documents, medical records, and the Investigator Site Files (ISF).
- Conducts Investigational Product (IP) review and accountability on site.
- Serves as point of escalation for clinical site management and investigator sites. Liaises with the in-house CRA interacting with investigator sites and responsible to support effective communications and resolution of issues.
- Maintains routine contact with investigator sites between routine on-site monitoring visits.
- Identifies, assesses, and resolves issues related to site performance, program risks, data inconsistencies/deviations, quality and compliance. Re-educates investigator sites as required, escalates issues, and ensures implementation of corrective actions.
- Ensures all essential documents are complete and in place, filed to the study electronic trial master file (eTMF) and inspection-ready. Participates in eTMF QC activities and ensures consistency between ISF and eTMF.
- Manages query resolution with investigator sites and data management operations.
- Supports centralized risk-based monitoring oversight activities as assigned.
- May support the Study Manager to formulate regional monitoring strategy, forecasting of site visits and/or overall clinical monitoring plans.
- Provides oversight of CRO activities related to monitoring (when outsourced); may co-monitor with CRO or contracted CRAs.
- Supports the maintenance of documentation to clinical systems (Clinical Trial Management Systems [CTMS], electronic data capture [EDC], Interactive Response Technology [IRT], etc.) and related supporting documents (manuals, completion guidelines, etc.) in collaboration with other study team members and/or external vendors as applicable.
- May support development and revision of monitoring SOPs, processes, forms, templates, tools, etc. with aim of continual improvement and efficiency.
- Supports audits/inspections/inspection readiness activities through collaboration with relevant clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA or external regulatory agencies as applicable.
- Performs other tasks or responsibilities as assigned.
- Bachelors degree (B.A./B.S.) or equivalent in life sciences or related discipline.
- 6+ years experience as a Clinical Research Associate.
- Extensive knowledge of trial oversight activities, GCP/ICH and federal regulations, IRB/EC and Investigator responsibilities.
- Familiarity with clinical trial systems (i.e. CTMS, EDC, eTMF, etc.).
- Strong computer skills, including a high level of proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, etc.).
- Ability to work independently and as part of a team.
- Competencies: Multi-Tasking, Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Strong Written and Verbal Communications.
- If employee is Chicago based - this is a hybrid role based in the Chicago office and requires a minimum of three days per week in the office as feasible when not traveling. On-site requirements may change at managements discretion.
- Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
- Travel up to 75%.
About the Company
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