Description
The Senior Clinical Research Associate (Sr. CRA), Clinical Operations, will coordinate the activities associated with the evaluation, initiation, management, and close-out of clinical trials within the Clinical Operations Department. The Senior CRA role provides an outstanding opportunity to work in a cross-functional environment and collaborate with colleagues in Clinical Science, Biometrics, Regulatory & QA, Drug Safety, Medical Writing, and Program Management.Responsibilities:
- Identify, select, and monitor investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits
- Develop and maintain good working relationships with investigators and study staff
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
- Track progress of study including patient enrollment, monitoring visits
- Review key study quality metrics (e.g., eligibility, tumor assessments, primary endpoint data, etc.) and follow-up with the SET to determine appropriate action
- Investigate queries, monitor discrepancies
- Manage investigational product (IP) accountability and reconciliation process
- Responsible for review or approval of IP release packages
- Negotiate and manage the budget and payments for investigative sites, if applicable
- Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
- Clinical data review of data listings and summary tables, including query generation
- Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to manager or CRO as appropriate
- Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
- Assist with CRA training on protocols and practices consistent with GCP standards
- Assist in identification and hiring of appropriate CROs and third party study vendors
- Assist in the development of department or cross functional SOPs
- Collaborate with CRAs and Directors to identify Clinical Operation's; process needs
- Interact with internal work groups to evaluate departmental needs, resources and timelines
- Mentor, train, and supervise staff at a functional level
- Ensure each new direct report is on-boarded and trained per departmental guidelines and SOPs, if applicable
- Review and authorize activities to assess the workload of direct reports
- Identify any performance issues and ensure an appropriate and timely performance improvement plan is undertaken
- Identify training needs for direct reports and develop training plans to address those needs
Requirements
- Bachelor's degree in a scientific discipline or equivalent
- 5 years experience in the pharmaceutical/biotech industry including but not limited to 4 years overseeing trial management and 3 years of field monitoring experience conducting site qualification, initiation, routine, and close out monitoring visits.
- Oncology experience
- Strong computer skills (MS Office)
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines
- Thorough knowledge of clinical monitoring procedures
- Strong analytical and assessment skills
To find out more about Real please visit www.realstaffing.com