General Description:
The CRA will assume the role of a primary CRA.
The CRA will conduct site visits (i.e., PSSV, SIV, IMV, COV) and function as the site manager.
The CRA is responsible to build and maintain relationships with key site personnel and ensure an effective line of communication.
The CRA will also monitor data quality and patient safety through monitoring and site education.
CRAs are to complete all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.
Essential Functions of the job:
Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices
Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation
Develop collaborative relationships with investigative sites, and study vendors
Provide protocol and related study training to assigned clinical study sites
Attend disease indication and/or project specific training, as required
Maintain oversight of site performance by tracking metrics for enrollment, data entry into Case Report Forms (CRFs), protocol deviation trends, and overall site issues
Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues
Communicate site performance to the Clinical Study Team (CST)
Perform study-specific training with project team
Perform Serious Adverse Event (SAE) reconciliation and work with study sites to resolve discrepancies
Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).
Attend regional investigator meeting and site booster visits, as required
Provide audit/inspection preparation support to clinical study sites and ensure quality issues or findings are followed to resolution, as needed
Assist with other assigned clinical responsibilities within scope of role, as required
Supervisory Responsibilities:
Provides site level management for established protocols and portfolio under general supervision
Provides mentoring/support to CRAs for CRA related topics
Co-monitoring with CRAs and support site visits, as needed
Computer Skills:
Efficient in Microsoft Word, Excel, PowerPoint and Outlook
Familiar with industry CTMS and data management systems
Other Qualifications:
Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
Excellent communication and interpersonal skills
Excellent organizational skills and ability to prioritize and multi-task
Fluent in English (writing and speaking)
Travel:
Up to 70% travel
Education Required:
BS/BA in a relevant scientific discipline and minimum
of 2+ years of relevant Clinical Operations experience, and minimum of 1+ years of monitoring
experience.
Experience in global oncology trials
preferred.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.