Contract Clinical Research Associate

Organization: 
Ardea Biosciences/Astra Zeneca
Job Location: 
San Diego, CA 92121
Job Description: 

We are seeking a Clinical Research Associate (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, 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. 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 CRA should be able to work proficiently within the Site management group with little oversight by having a solid understanding of the aspects of site activities to support field CRAs and having a solid knowledge of the clinical research process.

Responsibilities include:
• CRAs will support clinical site management aspects and perform site level management tasks on one or more clinical trials, and will contribute to the Site Management functional group, including working on continuous process improvement initiatives
• Responsible for monitoring activities of vendor outsourced clinical site activities, and providing site management support
• May assist with the review of synopses, protocols and amendments, and responsible for ensuring creation of ICFs
• Responsible for working on site-level Study Documents (e.g. reference manuals, Laboratory manuals, CRF Completion Guidelines, forms, etc.) under the direction of a senior team member
• Responsible for reviewing and understanding the content of site-level project plans, including the monitoring plan for any assigned projects, drug accountability and reconciliation plans
• Manage sites to comply with drug accountability processes
• Meet clinical research project metrics and functional department metrics according to assigned tasks.
• Perform tasks and activities with fiscal awareness
• Work with sites and/or outsourced vendor to ensure safety reporting and follow-up is completed within project and regulatory timeliness, including confirmation of IRB submissions. As required, may assist with review of serious adverse events (SAEs), follow-up requests, and SAE reconciliation
• 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, clinical research study document review, review vendor scopes of work)
• Participate in site selection activities including conduct of site selection visits, and reviewing recommendations from vendors
• Conduct site management and monitoring visits (e.g. qualification visits (SQV), site initiation visits (SIV), interim monitoring visits (IMV), close-out visits (COV)) and demonstrate independence and proficiency in all types of visits
• Understand and adhere to completion of deliverables within study/project established project metrics
• Proactively identify areas of risk and establish preventive actions and/or mitigation strategies
• 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 day to day management of vendors in regards to their services to 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
• Meet established 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
• May organize and run internal meetings for process issues

Requirements: 

• 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 one or more of the following:
• Minimum of 3 years in the clinical research industry with relevant experience (e.g. clinical trial administration, monitoring)
• Developing independence in performing site monitoring (e.g. site selection, site initiation, interim monitoring and closeout visits) and site management activities
• Experience creating form documents, and contributing to review of procedures
• Must possess a valid passport, as appropriate
• Experience with electronic data capture, a plus
• Basic 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
• Knowledge of requirements related to clinical monitoring and ability to learn and understand applicable medical/therapeutic area knowledge and medical terminology
• Basic understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology
• Effective communication skills (listening, oral, written) and can communicate in English language (oral, written)
• Sound interpersonal and negotiation skills, is flexible and adapts to changing situations
• Organized and proficient at multi-tasking with strong 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
• Solid judgment, decision making skills and problem solving ability
• Willingness to travel at least 25%

Apply online at: www.ardeabio.com/careers

Contact Information: 

Apply online at: www.ardeabio.com/careers

About Our Organization: 

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.