Shire Lead Clinical Research Associate in Lexington, Massachusetts
Study Start-Up Activities:
Assists the study team(s) to design, develop, and deliver the clinical study within agreed timelines.
Provides clinical study start up expertise and ensures identified efficiencies within study start-up are implemented.
Assists in providing oversight of site identification and selection
Provides oversight of Clinical CRO activities regarding Legal review/negotiation/execution of confidentiality and site agreements.
Provides oversight of Clinical CRO activities regarding country and site specific informed consent documentation tracking, finalization and approval.
Ensures effective communication between Shire and the Clinical CRO.
Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors. (E.g. Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.)
Provides oversight of Clinical CRO Investigator background checks.
Assists in oversight of vendor shipment of clinical supplies (e.g. lab kits, test machines, equipment etc.) being sent to sites prior to initiation as necessary.
Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP.
Reviews Clinical Monitoring Reports and correspondence related to Pre-Study and Initiation Visits and follows-up with Clinical CRO to resolve open action items.
Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager.
Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System.
Assists and/or participates in planning and conduct of Investigator’s Meetings as necessary.
Study Maintenance Activities:
Assists Clinical Project Manager in tracking study related activities which are not appropriate to be outsourced.
Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Project Manager.
Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present.
Provides oversight of Clinical CRO activities regarding amendments to confidentiality and site agreements.
Provides oversight of Clinical CRO activities regarding amendments to country and site specific informed consent documentation tracking, finalization and approval.
Study Close Out Activities:
Assists study team with preparation for audits/inspections
Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Project Manager.
Liaises with Transparency group to ensure Clintrials.gov and results are updated/distributed accordingly.
Mentoring & Development Tasks
Provides mentoring as appropriate to other CRA/Sr. CRAs within the group.
Takes on career developmental activities/tasks as appropriate upon discussion with manager.
Maintains knowledge and act as team super user or subject matter expert for related systems and processes.
Maintains up to date training record attending internal/external training(s) as necessary.
Participates in inter-departmental workgroups to create or enhance processes.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.