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 rarediseases and other high-need conditions, and who lack effective therapiesto live their 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 Sr. Clinical Research Associate (Sr.CRA) is responsible for independently providing support to the ClinicalProject Manager(s) for day to day clinical study activities. The Sr. CRAalso provides support for existing departmental tasks and may take ondevelopmental tasks as appropriate upon discussion with manager. The Sr.CRA performs work within established protocols under general supervision.
Study Start-Up Activities:
Assists the study team(s) to deliver the clinicalstudy within agreed timelines.
Assists in authoring/contributing to clinical studydocuments and study related plans developed by Clinical CROs and vendors.(E.g. Clinical Trial Insurance, IWRS specs, Lab Manual, LicensingAgreements etc.)
Provides oversight of Clinical CRO Investigator backgroundchecks.
Assists in oversight of vendor shipment of clinicalsupplies (e.g. lab kits, test machines, equipment etc.) being sent to sitesprior to initiation as necessary.
Provides oversight of Essential Documents for InvestigationalMedicine Release as per relevant SOP.
Reviews Clinical Monitoring Reports andcorrespondence related to Pre-Study and Initiation Visits and follows-upwith Clinical CRO to resolve open action items.
Manages escalation of study related issues and communicatesas appropriate with Clinical Project Manager.
Responsible for the operational oversight of theClinical CRO with regards to data feed setup in the Clinical Trial
Assists and/or participates in planning and conductof Investigator's Meetings as necessary.
Study Maintenance Activities:
Assists Clinical Project Manager in tracking studyrelated activities which are not appropriate to be outsourced.
Reviews a percentage of monitoring visit reports for oversightand escalates issues to Clinical Project Manager.
Assists with agenda distribution & minute takingfor internal clinical study team meetings where formal documentation is neededand the Clinical CRO is not present.
Provides oversight of Clinical CRO activitiesregarding amendments to confidentiality and site agreements.
Assists with oversight of Clinical CRO activitiesregarding amendments to country and site specific informed consent documentationtracking, 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.
Development tasks may be assigned to a Sr. CRA asappropriate upon discussion with manger:
Provides clinical study start up expertise andensures identified efficiencies within study start-up are implemented.
Assists in providing oversight of site identificationand selection.
Provides oversight of Clinical CRO activitiesregarding Legal review/negotiation/execution of confidentiality and siteagreements.
Provides oversight of Clinical CRO activitiesregarding country and site specific informed consent documentationtracking, finalization and approval. Ensures effective communicationbetween Shire and the Clinical CRO.
Maintains knowledge and act as team super user orsubject matter expert for related systems and processes.
Maintains up to date training record attendinginternal/external training(s) as necessary.
Participates in inter-departmental workgroups tocreate or enhance processes.
Bachelor's degree required
At least 3-5 years of experience in similar/relevantjob (eg. Sponsor, CRO, or Clinical Study Vendor)
Ability to work 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 learn newsystems quickly
Strong knowledge of MS Word, Excel, PowerPoint andOutlook
Requires strong attention to detail in composing andproofing materials, establishing priorities, scheduling, and meetingdeadlines
Must be able to professionally interact andcommunicate with visitors, vendors, and individuals at all levels of theorganization
Must be able to work in a fast paced environment withdemonstrated ability to manage multiple competing tasks and demands
Ability to work successfully within across-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 well ascommunicate effectively
Ability to lead others to drive deliverables forward
Must be able to work in a fast paced environment
Demonstrate ability to prioritize multiple competingtasks
Ability to work with minimal supervision and completetasks according to deadlines
Availability 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.