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We are seeking a Senior Clinical Research Associate (Sr. CRA) who will support efforts to design, plan, monitor and execute clinical research project(s) and is accountable for management of site-level activities and deliverables. For projects assigned, Sr. CRAs shall be responsible to manage site-level activities as directed by the Clinical Research Manager for that project and in accordance with Ardea SOPs, Regulatory regulations/guidelines and project requirements. Sr. CRAs will collaborate with personnel within clinical operations and across functions to ensure adherence to Ardea standard operating procedures and study specific parameters, and to facilitate consistency across projects. The Sr. CRA understands all processes within the SM team to mentor and direct others, has a broader perspective of the clinical research process, and can function independently on assigned projects. The Sr. CRA is given increased responsibilities to lead specific activities and can resolve issues, take decisions, and escalate issues appropriately.
• Sr. CRAs may function as leader for clinical site management aspects on one or more clinical trials, and will contribute to the Site Management functional group, including working on continuous process improvement initiatives
• Responsible for ensuring deliverables, where assigned, as lead for clinical research project(s), including leading other team members within the clinical site management group
• Responsible for management of day to day activities of vendor outsourced clinical site activities, including ensuring vendors meet related deliverables
• May manage small clinical study as Clinical Study Team Lead under the supervision of a Manager of Clinical Operations or higher
• Assists with the preparation of and/or review of synopses, protocols and amendments, and responsible for ensuring creation of ICFs
• Responsible for ensuring development of site-level Study Documents (e.g. reference manuals, Laboratory manuals, CRF Completion Guidelines, forms, etc.) and availability of site supplies (e.g. laboratory kits, clinical trial materials, etc.) within designated timelines
• Responsible for ensuring development of, contributing to and/or writing site-level project plans, including the monitoring plan for any assigned projects, drug accountability and reconciliation plans
• Manages drug accountability process, working with Pharmaceutical Science personnel regarding any drug-related issues (e.g., re-test updates and documentation, drug supply updates, etc.)
• Produce and provide clinical research project metrics and functional department metrics as required
• Responsible for ensuring activities being conducted and/or overseen by the Sr. CRA are within established budget parameters.
• Coordinate with safety management the flow of information to sites of safety updates and follow-up regarding timeliness and confirmation of IRB submissions. As required, may assist with review of serious adverse events (SAEs), follow-up requests, and SAE reconciliation
• Responsible for ensuring clinical research project team is provided site-level information as appropriate for required reports, including but not limited to CSRs, safety reporting, etc.
• Where applicable, Sr. CRA will participate in review of study results documents and report requirements, including but not limited to review of CSRs, annual safety reports, Case Report Forms, data tables and listings, etc.
• Carries out job responsibilities and assignments safely and maintain a clean and safe work area
• Other duties as assigned (e.g. assist other departments with ad hoc assignments related to cross study data review, etc.)
• Participate in site selection activities. Depending on the scope of assigned project this may include input on country selection, feasibility, and management of the site selection process.
• As required by assigned project, conduct site management and monitoring visits (e.g. qualification visits (SQV), site initiation visits (SIV), interim monitoring visits (IMV), close-out visits (COV))
• Co-monitoring visits as determined by project requirements
• Identify and establish site related quality metrics and deliverable metrics based on study requirements
• Proactively identify areas of risk and establish preventive actions and/or mitigation strategies
• Where outsourced, provide oversight of CRO monitoring activities including review of metrics representing quality and deliverables (e.g. monitoring visits, data collection activities, data query rates, etc.) as well as direct oversight of clinical monitor activities (e.g. trip report review, co-monitoring)
• Continuously identify areas for improvement and work with the appropriate departments and/or vendors to meet, maintain or exceed established standards, and initiate, develop and execute plans for correction where required
• Participate in identification and selection of vendors for site-level activities
• Participate in review of scopes of work related to these vendors, and be responsible for ensuring manuals, guidance documents and training are created and implemented at the sites
• Effectively communicates to internal stakeholders (e.g., Pharmaceutical Sciences, Regulatory Affairs, Data Management, Biostatistics) and external study team members, as appropriate, to ensure adequate distribution of information and coordination of activities
• Ensure the team tracks and manages deliverables and/or escalates issues that may jeopardize budget, timelines and deliverables
• Participates in cross functional team work for assigned study team(s) and internal processes
• Coordinate activities within Ardea and external vendors in order to manage studies from design to completion
• May organize and run internal meetings for process issues.
• Bachelor's degree or licensed certified health care training or equivalent combination of education and experience
• In-depth understanding and extensive experience working within clinical development as demonstrated by:
o Approximately 5-9 years in the clinical research industry with relevant experience (e.g. leadership role in a relevant functional area other than clinical operations, site management/monitoring); and
o 2-3 years of demonstrated proficiency in all aspects of site monitoring/management
• Demonstrated independence in performing site monitoring (e.g. site selection, site initiation, interim monitoring and closeout visits) and site management activities
• Experience writing procedures and creating form documents
• Must possess a valid passport, as appropriate
• Experience with electronic data capture, a plus
• Strong understanding and demonstrated application of clinical development guidelines, applicable regulatory authority requirements and guidances (e.g. ICH-GCP, FDA guidelines, US CFRs, EU Directive etc.), and Ardea Standard Operating Procedures
• Effective clinical monitoring skills and demonstrated ability to learn and understand applicable medical/therapeutic area knowledge and medical terminology
• Solid understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology
• Able to lead, motivate and coordinate teams. Coach/mentor team members as appropriate. Experience liaising with and coordinating cross-functional project teams
• Able to delegate, effectively prioritizes own workload and workload of delegated team members
• Effective communication skills (listening, oral, written) and can communicate in English language (oral, written)
• Sound interpersonal skills, is flexible and adapts to changing situations
• Applies a range of negotiation techniques to achieve desired outcomes
• Organized and proficient at multi-tasking with excellent attention to detail
• Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
• Possesses cross cultural awareness and is able to adapt appropriately
• Effective organizational and time management skills
• Ability to work in a team or independently as required
• Good presentation skills
• Excellent judgment, decision making skills and problem solving ability
• Able to communicate in English, both orally and in writing
• Willingness to travel up to 25%
Apply online at: www.ardeabio.com/careers
Apply online at: www.ardeabio.com/careers
Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases.