Clinical Research Associate II

Summary

The CRA II will perform clinical research duties that may include participation in the following areas: protocol development, planning, implementation, conduct/oversight, clinical study monitoring and management, study budgets, CRO management and reporting.

Responsibilities

• Contributes to or leads the preparation and finalization of clinical study protocols, final reports, and clinical summaries.
• Organizes materials for clinical study conduct including, but not limited to, model informed consent forms; study manuals; case report forms (CRF’s); clinical monitoring plan; data audit worksheet; clinical monitor safety evaluation guidelines; site regulatory binder; budget worksheet; subject status tracking and reference information for investigational sites.
• Participates in the planning and execution of Investigator Meetings.
• Confirms the qualifications of investigators, medical centers, and investigational sites throughout the conduct of a clinical study and assesses adherence to Good Clinical Practice (GCP).
• Evaluates the monitoring plan throughout the conduct of a clinical study and revises as needed.
• Independently monitors clinical study sites and documents all findings, outcomes, and agreements reached during site visits. Resolves discrepancies and ensures proper maintenance of site’s regulatory binder.
• Periodically reviews adverse events reported in a clinical study for the identification and evaluation of safety issues and any “patterns” that are identifiable and reported to medical and Regulatory Affairs. Oversees the required communication to the investigators as per the regulatory guidelines.
• Manages data discrepancies for the entire study or for assigned clinical study site(s) and coordinates the clinical monitoring activities to ensure that these discrepancies are resolved in the established timeframe for resolution.
• Manages current product inventory throughout clinical study (retention samples for QA; laboratory studies product; clinical study product). Revises the clinical product inventory needs as indicated and communicates the revision to the Clinical Project Team.
• Participates in or leads the selection & management of CROs or other study vendors as applicable.
• Tracks the day-to-day progress of clinical site activities. Updates the clinical study subject status at regular intervals. Identifies problems/issues and reports findings to appropriate Clinical Manager.
• Reviews case report forms once monitored for safety issues, patterns, completeness and quality. Reports any problems/concerns to appropriate Clinical Manager.
• Generates investigator/site payment requests.
• Advises management of any observations about study conduct at clinical sites, including any suspicion of fraud or misconduct.
• Plans work schedule to meet project timelines.
• Negotiates clinical site and CRO budgets as needed.
• Represents the company at clinical sites and at external project meetings as required.
• Customarily and regularly exercises discretion and independent judgment in the performance of the duties described above.
• Performs under only general supervision; works along technical lines requiring special training, experience and knowledge.
• Other duties as assigned.

***1 YEAR EXPERIENCE AS A Clinical Research Associate***
REQUIREMENTS
• A BS degree, preferably in a scientific field.
• No less than one years of experience as a Clinical Research Associate with increasing responsibilities in study management are preferred.
• Experience in management of multiple sites as a Clinical Research Associate is preferred.
• Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States. Exhibits ability to learn and apply foreign regulations to the clinical trial/research process.
• Excellent verbal and written communication skills, in addition to excellent organizational skills.
• Ability to travel is required.