Newly combined with Baxalta, Shire is now the leadingglobal biotechnology company focused on serving people affected by rarediseases and highly specialized conditions. These diseases are oftenmisunderstood, undiagnosed and life-threatening. Our 22,000 employees come to work everyday with a shared mission: to develop and deliver breakthrough therapiesfor the hundreds of millions of people in the world affected by rare diseasesand other high-need conditions, and who lack effective therapies to livetheir lives to the fullest.
At Shire, we are dedicated to expanding, building andsustaining leadership across our key therapeutic areas through ourextensive portfolio of products, innovative pipeline and collaborativeapproach to working with diverse partners around the globe. We strive toearn and keep the trust of our patients, their families and physicians, andall others who support and advance their care. Working together, thepossibilities for our patients, healthcare partners and employees areunprecedented, with significant growth potential for our shareholders.
The in-house Lead Clinical Research Associate (LCRA)is responsible for independently providing support to the Clinical ProjectManager(s) for day to day clinical study activities. The LCRA worksindependently to manage study start-up activities for key identifiedclinical studies. The LCRA also provides support for existing departmentaltasks and provides mentoring to other CRA team members. The LCRA performswork within established protocols under general supervision.
Study Start-Up Activities:
• Assists the study team(s) to design, develop, anddeliver the clinical study within agreed timelines.
• Providesclinical study start up expertise and ensures identified efficiencieswithin study start-up are implemented.
• Assists in providing oversight of siteidentification and oversight and escalates issues to Clinical ProjectManager.
• Assists withagenda distribution & minute taking for internal clinical study teammeetings where formal documentation is needed and the Clinical CRO is notpresent.
• Provides oversight of Clinical CRO activitiesregarding amendments to confidentiality and site agreements.
• Provides oversight of Clinical CRO activitiesregarding amendments to country and site specific informed consentdocumentation tracking, finalization and approval
Study Close Out Activities:
• Assists study team with preparation foraudits/inspections
• Reviews clinical close out monitoring visit reportsfor oversight and escalates issues to the Clinical Project Manager.
• Liaises with Transparency group to ensureClintrials.gov and results are updated/distributed accordingly.
• Provides mentoring as appropriate to other CRA/Sr.CRAs within the group.
• Takes on career developmental activities/tasks asappropriate upon discussion with manager.
• Maintains knowledge and act as team super user orsubject matter expert for related systems and processes.
• Maintains upto date training record attending internal/external training(s) asnecessary.
• Participatesin inter-departmental workgroups to create or enhance processes.
• Bachelor's degree required (Advanced degree orcertification preferred but not required)
• Minimum 5 years of experience in similar role (eg.Sponsor, CRO or Clinical Study Vendor)
• In depth knowledge of operational start upactivities for phase I-IV clinical studies
• Ability tomentor peers to build on strengths/weaknesses and drive success
• Ability towork independently and take initiative
• Relevant experience in clinical research or relatedfield
• Adequate Good Clinical Practice training
• General knowledge of regulatory requirements andguidelines governing clinical research
• Comfortable with technology and ability to learnnew systems quickly
• Strongknowledge of MS Word, Excel, PowerPoint and Outlook
• Requires strong attention to detail in composingand proofing materials, establishing priorities, scheduling, and meetingdeadlines
• Must be ableto professionally interact and communicate with visitors, vendors, andindividuals at all levels of the organization
• Must be ableto work in a fast paced environment with demonstrated ability to managemultiple competing tasks and demands
• Ability towork successfully within a cross-functional team
• Understanding how their input and role coordinatemore effective business practices for Shire's Clinical Development businessand commitment to the culture, vision, and mission of Shire
• Ability to take ownership and manage tasks as wellas communicate effectively
• Ability tolead others to drive deliverables forward
• Must be ableto work in a fast paced environment
• Demonstrateability to prioritize multiple competing tasks
• Ability to work with minimal supervision andcomplete tasks according to deadlines
• Available for up to 10% domestic and/orinternational travel
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Supplement
Pay Transparency Policy
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.