Ardea Biosciences
Job Location: 
San Diego, CA
Job Description: 


· Sr. CRAs/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

Project Related Planning, Management and Execution

· 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/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/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.)


Education and Experience:
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:
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
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

Knowledge, Skills and Attributes:
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

Contact Information: 

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